Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

Sponsor
Shandong Tumor Hospital
Study ID
NCT07320586
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Camrelizumab 200mg，d1，q3w.Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of use for Carilizumab is 2 years
  • Nab paclitaxel — DRUG
    nab-paclitaxel 100mg/m2 D1、8，q3w， Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest treatment time for albumin bound paclitaxel is 6-8 cycles.

Study Details

This study was an open, single center, prospective cohort study design. Subjects with advanced gastric cancer who had received first-line chemotherapy (cohort 1) and systematic chemotherapy combined with immunotherapy (cohort 2) were included in this study. 20 cases were included in each population, and a total of 40 subjects were planned to be included.

Key Dates

Start date
Mar 1, 2021
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Subjects with advanced gastric cancer who have been included in first-line treatment and have received systemic chemotherapy in the past. Administration method: Camrelizumab 200mg, d1, q3w, Albumin bound paclitaxel 100mg/m2 on days 1 and 8, q3w， Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of administration for Camrelizumab is 2 years, while the longest duration of treatment for albumin bound paclitaxel is 6-8 cycles.
  • Experimental: Group 2
    Advanced gastric cancer subjects included in the first-line treatment progression, who have previously received systemic chemotherapy combined with immunotherapy in the first-line treatment Administration method: Camrelizumab 200mg, d1, q3w, Albumin bound paclitaxel 100mg/m2 on days 1 and 8, q3w， Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of administration for Camrelizumab is 2 years, while the longest duration of treatment for albumin bound paclitaxel is 6-8 cycles.

Primary Outcome Measure

mPFS [ Time Frame: [Time Frame: The longest follow-up period from the patient's enrollment to disease progression or death from any cause is 2 years] ]

Central Contacts

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