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Camrelizumab and Chemotherapy With or Without Anlotinib as First-line Treatment for Advanced Gallbladder Cancer and Extrahepatic Cholangiocarcinoma

NCT06901622 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-30

No results posted yet for this study

Summary

To evaluate the efficacy and safety of camrelizumab and chemotherapy with or without anlotinib as first-line treatment for advanced gallbladder cancer and extrahepatic cholangiocarcinoma

Conditions

  • Gallbladder Cancer and Extrahepatic Cholangiocarcinoma

Interventions

DRUG

Camrelizumab, anlotinib, nab-paclitaxel, S-1

Initial treatment (4 cycles) Carrelizumab: 200 mg, day 1, iv, q3w. Anlotinib: 10 mg, taken orally once a day, day 1\~14, q3w. For patients with intolerance, the dose can be reduced to 8 mg. Nab-paclitaxel: 200 mg/m\^2, day 1, iv, q3w. (Patients with poor tolerance can be given on the 1st and 8th days, and the total dosage remains unchanged). S-1: 60 mg/day for body surface area \<1.25 m\^2; 80 mg/day for body surface area = 1.25\~1.50 m\^2; 100 mg/day for body surface area \>1.50 m\^2; 2 times a day, administered on days 1 to 14, 3 weeks as a treatment cycle. After 4 cycles of initial treatment, the feasibility of surgery was evaluated. Operable patients: radical surgical resection, followed by 4 cycles of S-1 combined with carrelizumab (up to 1 year). During postoperative treatment, the investigator determined whether local radiotherapy (CCRT) was required. Inoperable patients: carrelizumab + anlotinib + S-1 were treated until intolerance or disease progression.

DRUG

Camrelizumab, nab-paclitaxel, S-1

Initial treatment (4 cycles) Carrelizumab: 200 mg, day 1, intravenous drip, 3 weeks as a treatment cycle. Nab-paclitaxel: 200 mg/m\^2, day 1, intravenous drip, 3 weeks as a treatment cycle. (Patients with poor tolerance can be given on the 1st and 8th days, and the total dosage remains unchanged). S-1: 60 mg/day for body surface area \<1.25 m\^2; 80 mg/day for body surface area = 1.25\~1.50 m\^2; 100 mg/day for body surface area \>1.50 m\^2; 2 times a day, administered on days 1 to 14, 3 weeks as a treatment cycle. After 4 cycles of initial treatment, the patient's surgical feasibility was evaluated. Operable patients: radical surgical resection, followed by S-1 (4 cycles) combined with carrelizumab treatment (up to 1 year). During postoperative treatment, the investigator determined whether local radiotherapy (CCRT) was required. Inoperable patients: carrelizumab + S-1 treatment until intolerance or disease progression.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-08
Primary Completion
2026-03-01
Completion
2027-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06901622 on ClinicalTrials.gov