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

Conditions

• Gallbladder Cancer and Extrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Camrelizumab, anlotinib, nab-paclitaxel, S-1 — DRUG
  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.
• Camrelizumab, nab-paclitaxel, S-1 — DRUG
  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.

Study Details

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

Key Dates

Start date

Nov 8, 2024

Status verified

Nov 2024

Primary completion

Mar 1, 2026

Completion

Jul 1, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Camrelizumab, anlotinib, nab-paclitaxel, S-1
• Experimental: Cohort 2
  Camrelizumab, nab-paclitaxel, S-1

Primary Outcome Measure

Objective Response Rate, ORR [ Time Frame: Time Frame: about 2 years ]