Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT05669807
Phase
PHASE2
Status
Unknown

Conditions

  • Second Line Treatment of Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
15 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200mg d1, the first day, every 14 days as a cycle
  • Albumin-Bound Paclitaxel — DRUG
    100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle
  • Irinotecan — DRUG
    180 mg/m2, the first day, every 14 days as a cycle

Study Details

This study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.

Key Dates

Start date
Dec 31, 2022
Status verified
Dec 2022
Primary completion
Nov 30, 2023
Completion
Nov 30, 2025

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A: Camrelizumab+Albumin-bound paclitaxel
    Camrelizumab 200mg d1, one cycle every 14 days on the first day; albumin binding paclitaxel: 100 mg/m2, one cycle every 28 days on the first, eighth and fifteenth days
  • Experimental: B: Camrelizumab+Irinotecan
    Camrelizumab 200mg d1, the first day, every 14 days as a cycle Irinotecan: 180 mg/m2, the first day, every 14 days as a cycle

Primary Outcome Measure

Objective Response Rate [ Time Frame: up to 12 weeks ]

Central Contacts