Neoplasms

All Conditions

Rare Diseases

Adenocarcinoma

Cholangiocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cetuximab

Oxaliplatin

Antimetabolites

Antineoplastic Agents, Immunological

Intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks.

Arm A will receive E-GEMOX with additional intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above.

GEMOX (intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks

gemcitabine, oxaliplatin

E-GEMOX: intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above. All of the study medication will be administrated on day 1 every 2 weeks, which is regarded as one cycle.

cetuximab, gemcitabine, oxaliplatin

Li Tz Chen, PHD

Tsang Wu Liu, MD

The primary objective is to investigate the objective response rate in patients receiving GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or metastatic unresectable BTC biliary tract cancer compared to patients receiving the same chemotherapy without cetuximab. The secondary objectives include the exploration of the effect of the multimodality strategy on progression-free and overall survival, biomarker prediction, and toxicity.

It is considered realistic, that within 18 months 120 patients can be included in the participating centers. Based on the previous publications an objective response rate (ORR) of 20% is expected in the GEMOX arm (Arm B). When the sample size of evaluable patients is between 110 and 120 evaluable patients (ie. 55 to 60 patients per treatment arm), then a two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB, of 20% and an arm A response rate PA of 30%, 35% or 40% based on the large sample normal approximation will have a width between 15.4% and 16.7%. We assume an objective response rate of 30% for Arm A, then a two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB, of 20% and an arm A response rate PA of 30% will have a width ±15.4% when the sample size of evaluable patients is 120 (i.e., 60 patients per treatment arm).

A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC

A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin (GEMOX) With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer (BTC)

Evaluation of tumor response according to RECIST 1.1 version Evaluation will be done at baseline and every 8 weeks. Evaluation will be performed with CT or MRI.

Treatment toxicity will be graded by NCI Common Toxicity Criteria Version 4.0 (CTC, v4.0) for safety evaluation

National Taiwan University Hospital

Taipei Veterans General Hospital, Taiwan

Mackay Memorial Hospital

Tri-Service General Hospital

Chang Gung Memorial Hospital

Taichung Veterans General Hospital

China Medical University Hospital

National Cheng-Kung University Hospital

Kaohsiung Medical University

Kaohsiung Veterans General Hospital.

National Health Research Institutes, Taiwan

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Sarcoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Carcinoid Tumor

Ichthyosis, X-Linked

Soft Tissue Sarcoma

Subjects will receive RP2D surufatinib daily treatment continuously with every 28-day treatment cycle. Four expansion cohorts will enroll BTC, pNET, EP-NET, and STS patients, respectively.

orally once daily (QD) in patients with advanced solid tumor.

surufatinib

Vijay Jayaprakash, MD

Primary Objective Dose Escalation:

To evaluate the safety and tolerability of surufatinib in patients with advanced solid tumors and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D).

Primary Objective Dose Expansion:

To evaluate the anticancer activity of surufatinib in patients with advanced Biliary Tract Cancer (BTC), patients with advanced pancreatic neuroendocrine tumors (pNETs), patients with locally advanced, unresectable, metastatic extra-pancreatic neuroendocrine tumors (EP-NETs), and patients with soft tissue sarcomas (STS) treated at a dose of 300 mg QD.

Secondary Objective:

To evaluate the pharmacokinetic profile of multiple dose surufatinib in patients with advanced solid tumors and to evaluate the anti cancer activity of surufatinib in patients with advanced solid tumors.

The study is an open-label, dose escalation and expansion clinical trial of surufatinib orally once daily (QD) in patients with advanced solid tumors.

The study consists of two phases:

Dose escalation phase - A 3+3 design will be used for this portion of the study.

* Approximately 15 to 35 evaluable patients will be enrolled. The actual number of patients depends on the Dose-limiting toxicity (DLT) situation as well as the RP2D dose level reached in this trial.
* The trial will approximately evaluate five surufatinib dose levels at 50,100, 200, 300 and 400 mg/day.

Expansion phase:

Approximately 105 patients will be enrolled into one of four open-label treatment arms during this phase: at least 30 patients with advanced BTC that has progressed on standard ﬁrst-line chemotherapy will be assigned to Arm A, at least 15 patients with advanced pNET that has progressed on either everolimus, sunitinib, or both will be assigned to Arm B, at least 15 patients with advanced EP-NET that has progressed on everolimus will be assigned to Arm C, and at least 45 patients with Soft Tissue Sarcoma will be assigned to Arm D. Subjects enrolled in this phase are to be evaluated for the safety, tolerability and pharmacokinetic (PK) characteristics to confirm the selected surufatinib dose.

Subjects will receive surufatinib daily treatment continuously with every 28-day treatment cycle until disease progression, death, or intolerable toxicity at the investigator's discretion for a favorable benefit to risk balance.

A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors

A Multi-Center, Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Surufatinib (HMPL-012), Previously Named Sulfatinib in Advanced Solid Tumors

The primary outcome during dose escalation will be the incidence rate of DLTs

The primary outcome during dose expansion will be the PFS rate for each cohort

Blood samples will be taken to measure the levels of study drug.

Blood samples will be taken to measure the levels of study drug

the proportion of subjects who have a Complete Response or Partial Response

Hutchison Medipharma Limited

Digestive System Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Antibodies

Antibodies, Monoclonal

Immunoglobulins

This is a single arm trial. Participants will receive SHR1210 + GEMOX treatment.

28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond chemotherapy until the disease progression or untolerable toxicity.

SHR-1210+GEMOX

Yongqian Shu, PhD

This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies.

In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.

28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity.

SHR-1210 in Combination With GEMOX in Patients With Advanced BTC

A Single-arm, Open-label and Exploratory Clinical Study of PD-1 Monoclonal Antibody SHR-1210 in Combination With GEMOX (Gemcitabine Combined Oxaliplatin) in Patients With Advanced Biliary Tract Cancer

the rate of 6-month progression free survival

Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events

Jiangsu HengRui Medicine Co., Ltd.

The First Affiliated Hospital with Nanjing Medical University

Pembrolizumab

Immune Checkpoint Inhibitors

Experimental:

Pembrolizumab + SMT-NK inj. Participants will be randomized to receive 200 mg pembrolizumab followed by 3\*10\^6cells/kg SMT-NK inj.

Interventions:

Drug: SMT-NK inj. Drug: Pembrolizumab

Placebo Comparator: Pembrolizumb Participants will be randomized to receive 200 mg pembrolizumab.

Intervention:

Drug: Pembrolizumab

SMT-NK inj. will be administered as an intravenous (IV) infusion on Day 1,Day 7 of each 21-day cycle.

Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

SMT-NK inj.+Pembrolizumab

Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

JUNGMIN IM

HAEJIN IM

SANGMYUNG WOO

Seung Woo Park, MD. PhD

Sung Ill Jang, MD. PhD

SEUNGWOO PARK

This study is designed to assess the antitumor activity of combination therapy of SMT-NK (allogeneic natural killer cells) and pembrolizumab versus pembrolizumab monotherapy in patients with advanced biliary tract cancer

The term of biliary tract cancer (BTC) refers to all tumors that arise from the biliary tract or the biliary drainage system, including the gallbladder.Biliary tract cancer is one of the most poorly prognosis cancers and the five-year survival rate remains at about 10% as it is difficult to expect long-term survival due to frequent local recurrence and remote metastasis after surgery.

South Korea belongs to a country with a high number of biliary tract cancer patients, and the incidence of biliary tract cancer is actually increasing every year.According to the 2018 National Cancer Registration Statistics, the number of 5-year biliary tract cancer patients was 13,967 (7,547 men and 6,420 women), which corresponds to about 2.9% of all cancersand the 5-year survival rate of biliary tract cancer patients between 2014 and 2018 was 28.8%, showing a lower survival rate than other cancer species.

Most of the long-term survival is due to early detection by screening, but advanced carcinoma is a refractory carcinoma with a 5-year survival rate of less than 5%.In addition to standard anticancer drugs, alternative anticancer drugs and targeted treatments can be developed for cancer with a large number of patients, but biliary tract cancer is difficult to find any more treatments if standard treatment fails and standard anticancer treatments cannot be continued due to resistance.

Natural killer cells (NK cells) are innate lymphocyte cells with cell killing activity, and have the characteristic of destroying cells by secretion of and granzyme into cancer cells and abnormal cells that are reduced or deficient in expression of MHC class I.Clinical studies using natural killer cells as anticancer drugs have long been conducted on various cancers.

Pembrolizumab is a monoclonal antibody designed to bind to a receptor called PD-1, which is expressed by immune cells such as T cells.Natural killer cells were also found to be expressing PD-1 in the same way as T cells, and in particular, PD-1 was found to be higher in cancer patients than in healthy people.

Therefore, combined therapy with the immune-check point such as pembrolizumab can be useful in elevating the anticancer activity of NK cells.

Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer

Randomized, Placebo-controlled, Open-label, Phase 2b Clinical Trial to Evaluate the Antitumor Activity of Combination Therapy of SMT-NK and Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer

Progression-free survival (PFS) is defined as the time from the date of initial administration of the clinical trial drug to the progression or death due to any cause of the disease

Objective response rate (ORR) is defined as the ratio of subjects whose best overall response (hereinafter referred to as BOR) is partial response (PR) or complete response (CR) assessed by RECIST Version 1.1 and iRECIST.

Time to disease progression (TTP) is defined as the time from the first administration date of the clinical trial drug to the first disease progression

Overall survival(OS) is defined as the time from the date of first administration of the clinical trial drug to the death of all causes

Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first disease progression or death due to any cause.

Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by RECIST Version 1.1 and iRECIST

In order for the best overall response (BOR) to be finally evaluated as partial response (PR) or complete response (CR), it must be evaluated as partial response (PR) or complete response (CR) in two consecutive evaluations by RECIST Version 1.1 and iRECIST.

The time to response (TTR) is defined as the time from the date of first administration of the clinical trial drug to the time when it is evaluated as the first partial response (PR) or full response (CR) by RECIST Version 1.1 and iRECIST.

Assessed by EORTC-QLQ(The European Organization for Research and Treatment-QoL questionnaire) C30

SMT bio Co., Ltd.

Intrahepatic Cholangiocarcinoma

Immunomodulating Agents

Durvalumab

Tremelimumab

Durvalumab in combination with Tremelimumab

Arndt Vogel, Professor

Doerthe Vortmeyer, Doctor

Gunnar Folprecht

Ken Herrmann

Petra Buechner-Steudel

Arndt Vogel

Udo Lindig

Martin Fuchs

Jens Ricke

Salah-Eddin Al-Batran, Professor

A multicenter Phase II, randomized, prospective, open-label Trial investigating the clinical impact on combining Specific Internal Radiotherapy (SIRT) with the PD1-L Inhibitor Durvalumab and the CTLA-4 Inhibitor Tremelimumab in patients with intrahepatic Biliary Tract Cancer

IMMUWHY Phase II Clinical Trial will test the Addition of the immunotherapeutic agents Durvalumab and Tremelimumab after an initial Standard of Care SIRT in patients suffering from non-resectable intrahepatic Biliary Tract Cancer. Patients will be randomized into two experimental arms, one receiving Durvalumab only, the other one receiving Durvalumab + Tremelimumab. Clinical Outcomes will be compared vs. historical datasets.

Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)

Phase II Study of Immunotherapy With Durvalumab (MEDI4736) or Durvalumab and Tremelimumab, Both Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)

Exploratory: Predictive biomarkers that with a potential effect on Objective Response Rate, Duration of Response, Progression Free Survival and Overall Survival via blood sample collection + genetic subset analysis. The following translational research is currently planned, but may be adapted taking into account new research data: Tumors will be tested for mRNA expression of PD-1, PD-L1 and PD-L2 expression, Immune cell infiltrates (IGHM, CD3, CD8, FOXP3, CD68, CD205), Chemokines (CXCL9. CXCL10, CXCL13) and invasion markers (MMP7, MMP9)

Proportion of allocated subjects with best response of complete or partial response

Type, incidence and severity of AEs and SAEs graded according to NCI CTCAE v5.0

Time from that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the PD is objectively documented or death

Time from the date of randomization to the date of first observed disease progression (investigator assessment according to RECIST 1.1) or death from any cause

time from the date of treatment allocation to the date of death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC	NCT01267344	Cholangiocarcin... Adenocarcinoma ...	gemcitabine, ox... cetuximab, gemc...	20 Years -	National Health Research Institutes, Taiwan
A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors	NCT02549937	Tumors	surufatinib	18 Years -	Hutchmed
SHR-1210 in Combination With GEMOX in Patients With Advanced BTC	NCT03486678	Biliary Tract C... Cholangiocarcin...	SHR-1210+GEMOX	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer	NCT05429697	Biliary Tract C...	SMT-NK inj.+Pem... Pembrolizumab	19 Years - 80 Years	SMT bio Co., Ltd.
Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)	NCT04238637	Intrahepatic Ch...	Durvalumab Tremelimumab	18 Years - 99 Years	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC	NCT01267344	Cholangiocarcin... Adenocarcinoma ...	gemcitabine, ox... cetuximab, gemc...	20 Years -	National Health Research Institutes, Taiwan

Spots Global Cancer Trial Database for btc

Every month we try and update this database with for btc 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 btc

Every month we try and update this database with for btc 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 btc 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.