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

Phase 2

Active, not recruiting

• Conditions: Gallbladder Cancer; Hilar Cholangiocarcinoma; Distal Cholangiocarcinoma
• Interventions: Drug: Capecitabine; Drug: Toripalimab

• Registration Number: NCT06717464
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Both men and women aged ≥18 years old were eligible.
2. After radical surgery, postoperative pathological diagnosis of gallbladder cancer and Distal cholangiocarcinoma. TNM staging Ⅱ and above.
3. No systemic treatment before to participate in research;
4. ECOG PS score 0-1 points;
5. The main viscera function is normal, no serious blood, heart, lung, liver, kidney and bone marrow dysfunction, and immune deficiency disease.
6. 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.
7. Patients volunteered for and sign the informed consent;
8. Expect good adherence, can according to the plan calls for follow-up curative effect and adverse reactions.

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Exclusion Criteria

1. Postoperative pathology showed Pancreatic cancer and ampullary cancer;
2. 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;
3. Use of any other study medication within 4 weeks before enrollment;
4. 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;
5. People with innate or acquired immune deficiency, such as people with human immunodeficiency virus (HIV) infection;
6. 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;
7. 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;
8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
9. Live attenuated vaccine is administered within 4 weeks before the first dose or is planned for the duration of the study;
10. 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);
11. Known allergy to any of the trial drugs;
12. Pregnant, lactating women and subjects with reproductive capacity were unwilling to take effective contraceptive measures;
13. Suffering from uncontrollable psychosis; fourteen Other conditions that the investigator deemed inappropriate for inclusion. If the patient has central nervous system metastasis, serious laboratory abnormalities, accompanied by family or social factors, it will affect the safety of the subject, or the collection of data and samples.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capecitabine therapy group	Capecitabine	-
Toripalimab combined with capecitabine therapy group	Capecitabine	-
Toripalimab combined with capecitabine therapy group	Toripalimab	-

Primary Outcome Measures

Name	Time	Method
1-year recurrence-free survival rate	1 year

Secondary Outcome Measures

Name	Time	Method
2-year OS	2-year
1-year OS	1 year
Occurrence of adverse reactions	1 year

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China