NCT06901622

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

A Randomized Double-cohort Exploratory Clinical Study of Camrelizumab and Chemotherapy With or Without Anlotinib as First-line Treatment for Advanced Gallbladder Cancer and Extrahepatic Cholangiocarcinoma

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-11-08
• Primary completion: 2026-03-01
• Completion: 2027-07-01
• First posted: 2025-03-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: China