Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma

NCT04413734 | Unknown Phase 2

• 1 other identifier: CISLD-9
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to observe and evaluate the safety and the efficacy of the anti-programmed-death-1 antibody (anti-PD-1) Triprilumab in combination with chemotherapy of Gemcitabine PLUS Cisplatin in patients who were advanced intrahepatic cholangiocarcinoma with no chance for primary surgery.

Conditions

Intrahepatic Cholangiocarcinoma by AJCC V8 Stage

Keywords

Intrahepatic Cholangiocarcinoma; Immunotherapy; anti-programmed-death-1 antibody

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Time from first randomization to the first documented disease progression or death due to any cause, whichever occurs first.

  Observation period 48 months

Secondary Outcomes (6)

• Overall Survival (OS)

  Up to 48 months

• Objective Response Rate (ORR) per RECIST 1.1

  Up to 48 months

• Disease Control Rate(DCR)

  Up to 48 months

• Myopathologic response(MPR)

  Up to 48 months

• Conversion surgical resection(R0) rate

  Up to 48 months

Study Arms (2)

Triprilumab in combination with chemotherapy of GP

EXPERIMENTAL

Triprilumab, 240 mg, every 3 weeks (Q3W), Day 1 of each 3 week cycle PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity .

Drug: Combination therapy

Mono-chemotherapy of GP

ACTIVE COMPARATOR

Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity.

Drug: Mono-chemotherapy

Interventions

Combination therapy DRUG

Triprilumab by intravenous infusion accompanying with Gemcitabine plus Cisplatin

Also known as: Triprilumab, Immunotherapy, Anti-PD-1 therapy

Triprilumab in combination with chemotherapy of GP

Mono-chemotherapy DRUG

Gemcitabine plus Cisplatin by intravenous infusion

Also known as: Gemcitabine Injection plus Cisplatin Injection

Mono-chemotherapy of GP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma)
• Has at least one measurable, evaluable lesions based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the research center investigator
• Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
• Is willing to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
• Has a life expectancy of greater than 3 months
• Has adequate organ function
• Has EOCG score 0 or 1
• Has willing to voluntarily participate in clinical trial and sign informed consent

You may not qualify if:

• Histology includes fibrolamellar, hepatocytes, sarcomatoid liver cancer, hepatocytes, hepatocellular carcinoma and other components. Or has had previous biliary tract cancer (intra-or extra hepatic cholangiocarcinoma) or combined with other cancer with an exception of basal cell carcinoma and squamous cell carcinoma of the skin carcinoma in situ that has been radical treated.
• Has active tuberculosis and were receiving anti-tb treatment, or receiving anti-tb treatment within a year before were randomly assigned.
• Has symptomatic or poorly controlled circulatory disease, such as Congestive heart failure(NYHA III-IV), arrhythmia instability, type I angina, coronary heart disease, etc
• Has esophageal and gastric varices bleeding due to portal hypertension, or with history of inflammatory bowel disease, gastrointestinal perforation and intestinal obstruction, abdominal abscess, or chronic diarrhea.
• Has life-threatening bleeding or venous thromboembolism events occurred in the first six months before enrollment, or the patient was prone to severe bleeding or coagulation dysfunction, or was undergoing thrombolytic therapy
• Has active autoimmune disease requiring systemic treatment within the two years before enrollment , especially those with immunosuppressive drugs, who were unable to control or who needed large amounts of immunosuppressive drugs to control the disease, excluding topical glucose-corticosteroids or systemic use, and prednisone less than 10 milligrams per day
• Has central nervous system disease with symptoms, such as primary brain tumor, stroke, epilepsy, etc. Patients who have undergone central nervous system or known brain metastases
• Has acute or severe hepatitis infection, or a severe bacterial or bacterial infection in an active or clinically poorly controlled, or with congenital or acquired immune deficiency such human immunodeficiency virus (HIV) infected
• Has previous allogeneic stem cell or parenchymal organ transplantation, including after liver transplantation
• Has history of allergies to drugs involved in this study
• Women who are pregnant or lactating, or who do not want to use contraception during the trial.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Combined Modality Therapy; Immunotherapy; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Tingbo Liang

CONTACT

+8613666676128; liangtingbo@zju.edu.cn

Xueli Bai

CONTACT

+8613757166693; shirleybai@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 30, 2020
• First Posted: June 4, 2020
• Study Start: April 22, 2020
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2024
• Last Updated: June 4, 2020

Record last verified: 2020-05

Locations

CN (1)