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

Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer, Phase II, Single-center, Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hilar Cholangiocarcinoma; Gallbladder Cancer; Distal Cholangiocarcinoma
• Intervention / Treatment: Drug: Capecitabine; Drug: Toripalimab

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capecitabine therapy group	Drug: Capecitabine; 1250mg/m2, D1-D14, q3w, for 24 weeks (8 cycles)
Experimental: Toripalimab combined with capecitabine therapy group	Drug: Capecitabine; 1250mg/m2, D1-D14, q3w, for 24 weeks (8 cycles); Drug: Toripalimab; 240mg intravenous injection, q3w, for 54 weeks (18 cycles)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1-year recurrence-free survival rate	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
2-year OS	2-year
1-year OS	1 year
Occurrence of adverse reactions	1 year

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Gallbladder Diseases; Biliary Tract Neoplasms; Cholangiocarcinoma; Klatskin Tumor; Gallbladder Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Capecitabine
• Other Study ID Numbers: E20241189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No