Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer

NCT06717464 | Active Not Recruiting Phase 2

• 1 other identifier: E20241189
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled study to evaluate the efficacy and safety of toripalimab plus capecitabine as postoperative adjuvant therapy for patients with resectable advanced extrahepatic biliary tract cancer.

Conditions

Gallbladder Cancer; Hilar Cholangiocarcinoma; Distal Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• 1-year recurrence-free survival rate

  1 year

Secondary Outcomes (3)

• 1-year OS

  1 year

• 2-year OS

  2-year

• Occurrence of adverse reactions

  1 year

Study Arms (2)

Capecitabine therapy group

EXPERIMENTAL

Drug: Capecitabine

Toripalimab combined with capecitabine therapy group

EXPERIMENTAL

Drug: Capecitabine; Drug: Toripalimab

Interventions

Capecitabine DRUG

1250mg/m2, D1-D14, q3w, for 24 weeks (8 cycles)

Capecitabine therapy group; Toripalimab combined with capecitabine therapy group

Toripalimab DRUG

240mg intravenous injection, q3w, for 54 weeks (18 cycles)

Toripalimab combined with capecitabine therapy group

Eligibility Criteria

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

You may qualify if:

• Both men and women aged ≥18 years old were eligible.
• After radical surgery, postoperative pathological diagnosis of gallbladder cancer and Distal cholangiocarcinoma. TNM staging Ⅱ and above.
• No systemic treatment before to participate in research;
• ECOG PS score 0-1 points;
• The main viscera function is normal, no serious blood, heart, lung, liver, kidney and bone marrow dysfunction, and immune deficiency disease.
• Laboratory tests meet the following requirements: women of childbearing age must be within 14 days before the group for a pregnancy test results were negative serum or urine, and voluntary in the observation period and the last 8 weeks after with the study drug to adopt the appropriate methods of contraception; In men, either surgical sterilization or consent to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug was given.
• Patients volunteered for and sign the informed consent;
• Expect good adherence, can according to the plan calls for follow-up curative effect and adverse reactions.

You may not qualify if:

• Postoperative pathology showed Pancreatic cancer and ampullary cancer;
• The former group received PD 1, PD - L1, PD patients treated L2, CTLA 4, or directly to another stimulus or common weak T cell receptors (such as CTLA - 4, 0 x40, CD137) patients;
• Use of any other study medication within 4 weeks before enrollment;
• Have any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (eligible after hormone replacement therapy)); Patients with complete remission of childhood asthma without any intervention in adulthood or with white scarring were eligible, but those requiring medical intervention with bronchodilators were not eligible;
• People with innate or acquired immune deficiency, such as people with human immunodeficiency virus (HIV) infection;
• Patients with uncontrolled cardiac clinical symptoms or diseases, such as unstable angina pectoris with NYHA II or higher heart failure, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
• Severe infection (e.g., requiring intravenous antibiotics, antifungal, or antiviral drugs) within 4 weeks before the first dose, or unexplained fever \>38.5°C during screening/before the first dose;
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Live attenuated vaccine is administered within 4 weeks before the first dose or is planned for the duration of the study;
• Patients with or accompanied by other systemic malignant tumors within the last 5 years (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and ovarian cancer);
• Known allergy to any of the trial drugs;
• Pregnant, lactating women and subjects with reproductive capacity were unwilling to take effective contraceptive measures;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Gallbladder Neoplasms; Klatskin Tumor

Interventions

Capecitabine; toripalimab

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)