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

NCT05669807 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2023-01-03

No results posted yet for this study

Summary

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.

Conditions

  • Second Line Treatment of Gastric Cancer

Interventions

DRUG

Camrelizumab

200mg d1, the first day, every 14 days as a cycle

DRUG

Albumin-Bound Paclitaxel

100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle

DRUG

Irinotecan

180 mg/m2, the first day, every 14 days as a cycle

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Ji Zhu · Zhejiang Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-11-30
Completion
2025-11-30

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Entities

Drugs

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 NCT05669807 on ClinicalTrials.gov