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Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro

Formulate adjuvant chemotherapy strategy based on clinical experience

Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.

adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro

Jiaolin Zhou, Professor

Jiaolin Zhou, MD

Guo Lin, Professor

The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.

The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 \~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.

The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience.

The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C \>- Δ

PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer

Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy and Prognosis Judgment of Colorectal Cancer--Prospective Clinical Study

We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time

We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Time To Progress

Record the patient's PTC drug sensitivity results and the actual medication therapy, and record the patient's survival status through telephone follow-up, online follow-up and offline diagnosis to compare whether there is correlation between them.

We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Objective Response Rate

We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Progress Free Survival time

We follow-up the patients by outpatient/telephone/online message to find out their tumor and survival situation and record their Overall Survival time

Peking Union Medical College Hospital

Gland and Hormone Related Diseases

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Cancer, Papillary

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Papillary Thyroid Carcinoma

Vemurafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

All Groups: Vemurafenib 960 mg by mouth 2 times a day for 56 days prior to surgery (patients not planned for surgical resection will have a core biopsy at day 56 +/- 7 days).

Vemurafenib 960 mg by mouth two times a day 2 weeks post-surgery, or if patients have not sufficiently recovered at that point, as soon as their condition permits. Patients in Group A restaged 8 weeks after resuming drug. If patients in Group A demonstrate either stable or regressing disease, they will continue on vemurafenib with restaging occurring every 8 weeks until no longer benefitting from the drug.

Post Surgery - Group B: Patients discontinue vemurafenib after surgery but will be restaged with CT neck 8 weeks after surgery.

Patients not scheduled for surgical resection undergo a CT scan and core biopsy at day 56, Vemurafenib 960 mg by mouth twice a day unless there is evidence of progressive disease on day 56 CT scan. Patients evaluated for resectability after each CT scan is performed. If scheduled for resection, patient continues vemurafenib until surgery and follows same treatment schema as patients in Groups A and B.

960 mg by mouth 2 times a day 56 days prior to surgery (patients not planned for surgical resection will have a core biopsy at day 56.

Vemurafenib (All Groups)

Group A: 960 mg by mouth twice a day 2 weeks post-surgery. Restaged 8 weeks after resuming drug. If patients demonstrate either stable or regressing disease, they will continue on vemurafenib with restaging occurring every 8 weeks until they are no longer benefitting from the drug.

Group C: Patients not scheduled for surgical resection undergo a CT scan and core biopsy at day 56. Vemurafenib 960 mg by mouth twice a day, continued unless there is evidence of progressive disease on day 56 CT scan. Patients restaged every 8 weeks and continue vemurafenib until no longer benefitting from the drug. Patients evaluated for resectability after each CT scan is performed. If patient is scheduled for resection, then patient will continue vemurafenib until surgery and will follow the same treatment schema as patients in Groups A and B.

Vemurafenib (Post Surgery) - Group A + C

Patients who have had a complete surgical resection, and who do not have evidence of metastatic disease will discontinue vemurafenib after surgery. Patients restaged with CT neck 8 weeks after surgery.

Post Surgery - Group B

Maria E. Cabanillas, MD

The goal of this clinical research study is to learn about how vemurafenib may affect certain biomarkers in patients with PTC. Biomarkers are in the blood/tissue and may be related to your reaction to the study drug. The safety of this drug will also be studied.

Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer and cancer growth. By blocking this mutation, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing.

Study Drug Administration and Groups:

If you are found to be eligible to take part in this study, you will take 4 tablets of vemurafenib by mouth 2 times each day for 56 days. You should take each dose about 12 hours apart. If you miss taking the drug at a scheduled time by more than 4 hours, you should skip that dose and wait until the next dose.

After 56 days, the treatment you receive will depend on what group you are assigned to:

* If the disease has spread outside the neck, you will be in Group A.
* If the disease is able to be entirely removed through surgery, you will be in Group B.
* If the disease is unable to be operated on, you will be in Group C.

Study Visits:

At all visits, you will be asked about any side effects you may be having and about any other drugs you may be taking.

Before you take the study drug (Baseline):

* You will have a procedure called a laryngoscopy, in which a tube with a small camera in inserted into the nose to inspect your sinus, throat, and voice box.
* You will have a colonoscopy if you have a history of abnormal growth in the bowel (polyps or colon cancer). During this procedure a tube with a small camera is inserted in the anus to inspect your large bowel.

At Day 28:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* You will have an EKG.
* Blood (about 1 tablespoon) will be drawn for routine tests.

Within 1 week before Day 56, you will have CT scans of the neck, chest, and abdomen to check the status of the disease.

At Day 56, if you are in Group A or B, you will have surgery to remove the tumor. You will sign a separate consent form that describes this surgery and its risks. If you are in Group C, you will have a core biopsy. During the surgery/biopsy, blood (about 1 teaspoon) will also be collected for biomarker testing.

Follow-Up:

Your follow-up after the surgery/biopsy will depend on which study group you are in.

Groups A and C:

If you are in Group A, you will stop taking the study drug for about 2-4 weeks after you have surgery. If you are in Group C, you will not stop taking the study drug. Every 4 weeks (after you resume taking the study drug if you are in Group A, and after the biopsy if you are in Group C):

* You will have a physical exam, including measurement of your vital signs and a skin exam.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will be asked about any other drugs you may be taking and about any side effects you may be having.
* If you are in Group A, these tests will also be performed the day you start taking the study drug again. You will also have an EKG.

Additionally, every 8 weeks (if you are in Group A or C), you will have CT scans of the neck, chest, and abdomen to check the status of the disease. Blood (about 1 teaspoon) will also be drawn for biomarker testing at the first of these visits.

About 1 year after your laryngoscopy and colonoscopy, these procedures will be performed again to check for side effects related to the study drug. If you did not receive a baseline colonoscopy, this procedure will be performed about 1 year after starting vemurafenib. If you continue on study drug for more than a year, you will have a laryngoscopy every 12 months.

At any time the study doctor thinks it is needed, you will have a colonoscopy and laryngoscopy.

About 1 year after the surgery/biopsy, you will return to clinic to check if the disease has come back. At this visit, you will have a CT scan or ultrasound of the neck, and blood (about 1 tablespoon) will be drawn for tests of your thyroid function.

If after 4 months the study doctor thinks it is in your best interest, you will only need to have study visits every 8 weeks. You will still have blood (about 1 tablespoon) drawn for routine tests at a local lab and you will be called by the study staff to check on you. Each call will last about 5-10 minutes.

If you are in Group C, and if during follow-up the study doctor decides that the disease can be operated on, you will be crossed over to Group A or B. You will have surgery and have the follow-up visits described for that study group.

Group B:

If you are in Group B, you will have a follow-up visit about 2 weeks after surgery. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will be asked about any other drugs you may be taking and about any side effects you may be having.

You will have a second follow-up visit about 8 weeks after surgery. You will have a CT scan of the neck to check the status of the disease. You will have the option of continuing to receive vemurafenib if your doctor thinks it is in your best interest. If you do continue on vemurafenib, you will follow the Group A follow-up schedule (above).

About 1 year after your laryngoscopy and colonoscopy, these procedures will be performed again to check for side effects related to the study drug. If you did not receive a baseline colonoscopy, this procedure will be performed about 1 year after starting vemurafenib.

At any time the study doctor thinks it is needed, you will have a colonoscopy and laryngoscopy.

About 1 year after the surgery/biopsy, you will return to clinic to check if the disease has come back. At this visit, you will have a CT scan or ultrasound of the neck, and blood (about 1 tablespoon) will be drawn for tests of your thyroid function.

Length of Study:

If you are in Group A or C, you will continue to take the study drug for as long as the study doctor thinks it is in your best interest. If you are in Group B, you will take the study drug for 56 days and will no longer take it after surgery. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over when you have completed the follow-up visits.

End-of-Study Visit/Call:

After you stop taking the study drug, you will have an end-of-study visit or phone call. You will be asked about any other drugs you may be taking and about any side effects you may have had. If you are called, the call will last about 5-10 minutes.

This is an investigational study. Vemurafenib is FDA approved and commercially available for the treatment of late-stage melanoma. It is investigational to use this drug to treat thyroid cancer.

Up to 22 patients will take part in this study. All will be enrolled at MD Anderson.

Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer

Pharmacodynamic Study of Vemurafenib in the Neoadjuvant Setting in Patients With Locally Advanced Thyroid Cancer

ERK phosphorylation and tumor size measured at baseline before first dose of Vemurafenib and again after 56 days of Vemurafenib. We will test whether correlation between percent change in ERK phosphorylation and percent change in tumor size is different from 0 with a t-test.

Objective response rate defined as proportion of patients who have had a partial response (PR) or complete response (CR) after initiation of therapy with Vemurafenib, using RECIST 1.1. All patients who complete baseline and day 56 scans evaluable for this endpoint.

Genentech, Inc.

M.D. Anderson Cancer Center

Cholestasis

Percutaneous transhepatic cholangiography biliary drainage is compared tot endoscopic biliary drainage in the management of malignant biliary obstruction not amenable to ERCP

Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage

Schalk van der Merwe, MD, PhD

Frederik Nevens, MD, PhD

Werner Van Steenbergen, MD, PhD

Chris Verslype, MD, PhD

David Cassiman, MD, PhD

Wim Laleman, MD, PhD

Geert Maleux, MD, PhD

Patients with obstructive jaundice due to locally advanced/metastatic malignancy with dilated intrahepatic bile ducts will be recruited from the department of Gastroenterology and Hepatology at the University Hospital of Leuven.

This population will have failed ERCP or will be considered when ERCP is not possible due to altered surgical anatomy.

Patients will be randomized to either PTC or EUS guided biliary drainage

Background:

Advanced biliary tract malignancy complicated by obstructive jaundice has been traditionally managed by palliative stent placement at ERCP. In 3-12% of patients with advanced disease tumour involvement of the small bowel or peri-ampullary region may preclude the use of ERCP necessitating percutaneous transhepatic biliary drainage (PTBD) or surgery1. However these techniques have been associated with high complication rates and significant morbidity2. PTBD necessitates traversing the parietal and visceral peritoneum causing a potential for a bile leak and bleeding into the peritoneal cavity. This procedure is also associated with significant pain, lengthy hospital stays and an overall reduction in quality of life, and even procedure related mortality. Indeed the Society of Interventional Radiology (SIR) quality improvements guidelines established the procedural risk of severe major complications including sepsis, bleeding and procedural related death at 2.5% and less severe complications including pain and prolonged hospital admissions at 20%.

In recent years various groups have described endoscopic ultrasound guided access of the left system allowing placement of metal or plastic stents either across the distal stricture or deploying the stent in the stomach (hepatico-gastrostomy), with high technical success3. Retrograde cannulation normally performed from the duodenal bulb allows access to the biliary tract above a malignant stricture with the intent to either pass a guide wire through the papilla and then perform a rendezvous procedure, or the placement of a covered metal stent into the stomach (choledochoenterostomy)10. Cannulation of a dilated segment 2 or 3 sectoral duct is also possible from the proximal stomach where the endoscopist performs all procedures in an antegrade fashion5. Currently these procedures are selectively performed in centres by expert endoscopists from mainly tertiary care academic expert centres including in Leuven. Collectively EUS biliary drainage is technically successful in 75-92% of cases, however reports of bile leaking and peritonitis have been described5.

Various obstacles however still exist to extend the general applicability of this technique outside expert centres. Firstly, no randomized control trials exist comparing the safety and efficacy of EUS biliary access to Percutaneous Transhepatic Cholangiography (PTC). Secondly, current endoscopic techniques utilize standard endoscopic accessories not specifically developed to be utilized within the biliary system when advanced through the gastric wall. Thirdly, specific EUS strategies are needed to prevent or reduce complications associated with percutaneous approaches.

Concept and preliminary experimental data

Hypothesis

Based on the literature we hypothesize that:

* Endoscopic ultrasound guided biliary drainage is more effective than percutaneous biliary drainage in the management of obstructive jaundice
* EUS guided biliary drainage is associated with a reduced incidence of major (bile peritonitis, procedure related mortality, hematobilia) and minor (abdominal pain, prolonged hospital stay) complications.
* EUS guided biliary drainage is more cost effective compared to percutaneous biliary drainage

Aims of proposed research

Based on the current literature we propose a randomized pilot study assessing the following specific end points

* EUS biliary drainage is as effective as percutaneous biliary drainage in achieving resolution of cholestasis
* EUS biliary drainage is not associated with an increased risk of complications compared to percutaneous biliary drainage.

Methodology

Study population. Patients with obstructive jaundice due to locally advanced/metastatic malignancy with dilated intrahepatic bile ducts will be recruited from the department of Gastroenterology and Hepatology at the University Hospital of Leuven.

This population will have failed ERCP or will be considered when ERCP is not possible due to altered surgical anatomy.

Patients will be randomized to either PTC or EUS guided biliary drainage

Inclusion criteria:

* Patients older than 18 years presenting with malignant obstructive jaundice
* Locally advanced primary or metastatic malignancy involving the biliary tract
* Patients in whom an ERCP have failed or where an ERCP is not possible due to surgically altered anatomy (eg. Post-Whipple).

Exclusion criteria:

• Resectable biliary tract malignancy with curative intent

Endoscopic method

Linear array endoscopic ultrasound (Pentax, Pentax Hitachi, Montvale, NJ) will be used to identify the dilated left system. The Doppler mode was used to differentiate intrahepatic bile ducts from portal and hepatic vein branches. A 19G needle (Echo-19, Cook, Limerick, Ireland) will be used to puncture a peripherally located dilated segment 2 or 3 duct under EUS guidance. Under fluoroscopic control a cholangiogram will be obtained and a standard 0.035 guide-wire (Hydra Jag wire, Boston Scientific, Natick, MA Boston Scientific) will be advanced into the biliary system. Next a 6Fr cystotome (Endoflex, Voerde, Germany) will be used to create a trans-gastric tract through the liver parenchyma to the dilated biliary system. The guidewire will be manipulated across the stricture into the duodenal lumen. A Hurricane biliary dilation balloon 4cm x4mm (Boston Scientific, Natick, MA Boston Scientific) will be advanced through the tract and used to dilate the common bile duct stricture without balloon dilation at the level of the gastric wall liver interface. A 10mmx 80mm uncovered self expandable metallic stent (SEMS) will be advanced and deployed under fluoroscopy across the papilla and past the duodenal obstruction when present.

In patients were the left ductal system is not dilated, biliary access will be obtained from the duodenal bulb and a covered metal stent will be deployed in the stomach (choledocho-enterostomy).

In patients with duodenal obstruction a Wallstent will be placed at the same session as part of standard of care.

Novel research perspectives and expected outcomes

* Our research will address a very difficult clinical problem in an unique way: comparing the standard of care biliary drainage procedure (PTC) to EUS guided biliary drainage.
* We expect to demonstrate that EUS guided biliary drainage is as effective as PTC
* We also expect to show that EUS guided biliary drainage is associated with a reduced incidence of complications and reduced hospital stay.

Study endpoints

* Primary endpoints

  * Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and 72 hours following the procedures
  * Biochemical changes: Bilirubin decrease at 2 and 4 weeks
* Secondary endpoints

  * Major complications including bile leak, bleeding, sepsis or death
  * Duration of procedures in minutes
  * Length of ICU and hospital stay
  * Minor complications

Statistics power calculations It is assumed that 50% of the patients will experience prolonged pain after PTC defined as pain lasting more than 48 hours and requiring analgesics. 48 patients in total (24 per group) are then needed to detect with 80% power a difference with EUS, expecting 10% of the patients having prolonged pain after EUS. The sample size calculation is based on a two-sided Fisher's Exact test (with alpha=5%). To compensate for potential dropout, 7 additional patients in total will be recruited. Therefor the sample size will comprise of 55 patients. Exact 95% confidence intervals will be calculated for the proportion major complications in both groups. Proportions will be compared using a Fisher's Exact test. A Mann-Whitney U test will be used to compare the actual VAS scores and changes in VAS scores between groups. A log-rank test will be used to compare the length of hospital stay (LOS), censoring potential deceased patients at a value exceeding the highest observed LOS.

P-values smaller than 0.05 will be considered significant. Statistical analyses will be performed using SAS software, version 9.2 of the SAS System for Windowsld be given when defining the endpoints.

Investigators:

Department of Internal Medicine, Division of Hepatology: Prof. Frederik Nevens, Prof. Werner van Steenbergen, Prof. Chris Verslype, Prof. Wim Laleman, Prof. David Cassiman, Prof. Schalk van der Merwe

Department of Interventional radiology:

Prof. Geert Maleux, Dr. Sam Heye, Dr. Johan Vaninbroukx

Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage

Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage in Advanced Biliary Tract Malignancy That Failed ERCP (PETRUS Study): A Randomized Pilot Study

- Primary endpoints

* Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and 72 hours following the procedures
* Biochemical changes: Bilirubin decrease at 2 and 4 weeks

- Secondary endpoints

* Major complications including bile leak, bleeding, sepsis or death
* Duration of procedures
* Length of ICU stay
* Minor complications

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer	NCT05978349	Colo-rectal Can...	adjuvant therap...	18 Years - 75 Years	Peking Union Medical College Hospital
PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer	NCT05978349	Colo-rectal Can...	adjuvant therap...	18 Years - 75 Years	Peking Union Medical College Hospital
Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer	NCT01709292	Thyroid Cancer	Vemurafenib (Al... Vemurafenib (Po... Post Surgery - ...	18 Years -	M.D. Anderson Cancer Center
Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage	NCT01686425	Malignant Bilia...	Percutaneous tr...	18 Years -	Universitaire Ziekenhuizen KU Leuven
Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer	NCT01709292	Thyroid Cancer	Vemurafenib (Al... Vemurafenib (Po... Post Surgery - ...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ptc

Every month we try and update this database with for ptc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ptc

Every month we try and update this database with for ptc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ptc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.