Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Biliary Tract Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.

The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.

radioactive stent carrying seed iodine 125

radioactive stent

common plastic stent without carrying seed iodine 125

plastic stent

Yan Liu, MD,PhD

Zhaoshen Li, Doctor

Min Min, M.D. PhD.

Yan Liu, Doctor

The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.

Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).

In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death.

Overall survival was calculated from the date of randomization until the date of death.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Changhai Hospital

307 Hospital of PLA

PhD, MD. Chairman of Department of Gastroenterology and Hepatology, 307 Hospital of PLA

Antineoplastic Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Antibodies

Immunoglobulins

This is a single-arm, prospective, exploratory clinical study of unresectable or relapsing metastatic ampullary tumors who were not systematically treated with surufatinib in combination with PD-1 antibody and AG regimen.Until the investigator assesses loss of clinical benefit, unacceptable toxicity, decision by the investigator or subject to withdraw treatment, or death, whichever comes first.The AG regimen does not exceed 8 cycles, and maintenance therapy with surufatinib combined with toripalimab can be continued if the patient has not progressed after 8 cycles. The treatment period was 21 days; Tumor treatment and survival status were recorded until disease progression (RECIST 1.1) or death (during patient treatment).

Surufatinib (200mg，qd，Q3W）；Toripalimab(240mg IV d1, Q3W)；AG（Albumin-bound paclitaxel: 125mg/m2，IV，d1，d8，Q3W）Gemcitabine: 1000 mg/m2, IV，d1，d8，Q3W）

Surufatinib+Toripalimab+AG

Du Juan, M.D. Ph.D

A Phase Ⅱ, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With recurrent or metastatic ampulla tumors.

Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma

Efficacy and Safety of Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma

Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0

Symptoms and General Pathology

Constriction, Pathologic

1. Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive endobiliary radiofrequency ablation (Endobiliary RFA) followed by plastic stent(s) placement.
2. Three months later, subjects will receive the second RFA therapy followed by biliary stents (plastic or SEMS) placement.
3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA

1. Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive plastic biliary stent(s) placement only.
2. Three months later, subjects will receive the second endoscopic intervention for stents (plastic or SEMS) exchange.
3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA

The RFA probe is introduced into bile duct. Bipolar electronic coagulation is performed to the tumorous segment.

Radiofrequency ablation (RFA)

Bing Hu, MD, PhD

Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. But restoration of bile flow have few improvement of the survival of cancer patient. By using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth, which might improve the survival of patients. The feasibility and safety of this technique using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled, multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve the median survival of patients with unresectable biliary malignancy.

RFA is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. It uses bipolar electrical energy for tissue coagulation and can be easily applied during endoscopic retrograde cholangiopancreatography (ERCP). Endobiliary radiofrequency can destruct the tumor tissue and has potential benefit for controlling tumour growth. Several cohort studies have been published and the feasibility and safety of such technique has been proved.

The aims of this study is to conduct a randomised, controlled, multicentre clinical trial to compare the effect of endobiliary RFA plus biliary stenting with only biliary stenting in patients with unresectable cholangiocarcinoma or ampullary carcinoma.

The objectives are

* To evaluate whether endobiliary RFA prior to biliary stenting can improve the patients' survival as compared to the only stenting therapy.
* To assess the impact of RFA on the stent's patency.

Endobiliary RFA for Unresectable Malignant Biliary Strictures

Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial

Bing Hu

Professor, Head of Endoscopy Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Prostatic Neoplasms

Stomach Neoplasms

Sarcoma

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Urinary Bladder Neoplasms

Carcinosarcoma

Mixed Tumor, Mullerian

Leiomyosarcoma

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Fallopian Tube Cancer

Malignant Mixed Mullerian Tumor

Herbal and Botanical

Poly(ADP-ribose) Polymerase Inhibitors

Rucaparib

Enzyme Inhibitors

Cola

Eligible participants will be enrolled in either Cohort A or Cohort B.

Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.

Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.

Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).

Kim Reiss-Binder, MD

A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.

A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes

A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes

De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by Clovis Oncology.

Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.

Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.

Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.

Measure of clinical benefit, defined as the duration from study enrollment to death.

pharmaand GmbH

Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.

Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

Rucaparib Cohort A

Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

Rucaparib Cohort B

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Kim Reiss Binder

Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants).

Best Overall Response Rate by Investigator

No data were collected as the independent radiology review was not performed.

Overall Response Rate by Independent Radiology Review

Participants with a deleterious mutation in one of the following genes: BRD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

Duration of Response

Disease Control Rate

Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment.

Progression-free Survival

Overall Survival

Number of Participants Experiencing Treatment-emergent Adverse Events

Pharmacokinetics data not collected due to early study termination.

Steady State Minimum Concentration [Cmin]

Overall Study

Gallbladder Neoplasms

Gallbladder Diseases

Gallbladder Cancer

Antimetabolites

Vandetanib 300 mg as a once daily oral dose, from Day 1

Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)

Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).

300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

ZD6474, Vandetanib

100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Placebo matching ZD6474

Clinical Sciences & Operations

The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in patients with advanced (unresectable or metastatic) biliary tract cancer.

Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer

A Randomized, Multicentre, Phase II, Parallel-Group Trial of Vandetanib Monotherapy or Vandetanib in Combination With Gemcitabine Versus Gemcitabine Plus Vandetanib Matching Placebo in Subjects With Advanced Biliary Tract Cancer (Gallbladder Cancer, Cancer of the Extrahepatic Bile Duct, Intrahepatic Cholangiocarcinoma and Ampullary Carcinoma)

Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).

Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD

DCR is the sum of patients with a best overall CR, PR or SD (\>=8 weeks) by the patient in the analysis

DOR is defined from the date of first documentation of response until date of PD or death

OS is defined from the date of randomization to death

Genzyme, a Sanofi Company

Arm A Vandetanib 300 mg

Arm B Vandetanib 100mg + Gemcitab

ARM C Placebo+ Gemcitabine

Patient screened 180 Patient Randomized 174 (1 never treated) Sceening failures 6 Patient Treated 173 (ITT=165 ; 8 excluded from ITT due to missing postbaseline assesment)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer	NCT02238613	Intrahepatic Ch... Cholangiocarcin... Ampullary Carci... Biliary Obstruc...	radioactive ste... plastic stent	18 Years - 80 Years	307 Hospital of PLA
Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma	NCT06062485	Ampullary Carci...	Surufatinib+Tor...	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Endobiliary RFA for Unresectable Malignant Biliary Strictures	NCT01844245	Cholangiocarcin... Ampullary Carci...	Radiofrequency ...	18 Years -	Eastern Hepatobiliary Surgery Hospital
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes	NCT04171700	Solid Tumor	Rucaparib	18 Years -	pharmaand GmbH
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer	NCT00753675	Biliary Tract C... Gallbladder Can... Cancer Of The E... Ampullary Carci...	ZD6474, Vandeta... ZD6474, Vandeta... Gemcitabine Placebo matchin...	18 Years -	Sanofi
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer	NCT02238613	Intrahepatic Ch... Cholangiocarcin... Ampullary Carci... Biliary Obstruc...	radioactive ste... plastic stent	18 Years - 80 Years	307 Hospital of PLA
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer	NCT00753675	Biliary Tract C... Gallbladder Can... Cancer Of The E... Ampullary Carci...	ZD6474, Vandeta... ZD6474, Vandeta... Gemcitabine Placebo matchin...	18 Years -	Sanofi

Spots Global Cancer Trial Database for ampullary carcinoma