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

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 8, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

July 1, 2027

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."

Trial Locations (1)

450000

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

All Listed Sponsors
lead

The First Affiliated Hospital of Zhengzhou University

OTHER