The Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer

Sponsor
Xianglin Yuan
Study ID
NCT06592287
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Gastric Cancer

Eligibility Criteria

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

Interventions

  • Adebrelimab + Apatinib + Lrinotecan liposome — DRUG
    Adebrelimab 1200 mg, iv. q3w Apatinib 250 mg po qd Lrinotecan liposome 80mg/m2, iv. q3w Continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.

Study Details

This study is a prospective, dual arm, open Ib/II phase clinical trial, with the main objective of exploring the safety and efficacy of Adebrelimab combined with Apatinib and Lrinotecan liposome for second-line treatment of advanced gastric cancer. The study is divided into two stages. The first stage is the safety introduction period, which includes 6 patients. Observe whether the subjects experience dose limiting toxicity (DLT) during the observation period. If no subjects experience DLT during the observation period, the study enters the next stage. The dose of Lrinotecan liposome used during the safety introduction period is 80mg/m2, and the DLTs observation period is 1 cycle. If the patient cannot tolerate it, the dose will be reduced to 60mg/m2. In the second stage, advanced gastric cancer subjects who have progressed to first-line treatment will be included in two cohorts: those who have previously received immune checkpoint inhibitor therapy and have first-line PFS\>7m (cohort 1) and those who have received standard systemic chemotherapy (cohort 2). 30 subjects will be included in each population, and a total of 66 subjects are planned to be enrolled. The study includes a screening period (from the signing of the informed consent form by the subjects to the first treatment, not exceeding 28 days), a treatment period (Adebrelimab combined with Apatinib and Lrinotecan liposome), and a follow-up period (including safety and survival follow-up).

Key Dates

Start date
Sep 30, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: Frontline has received treatment with immune checkpoint inhibitors
    Previously received first-line treatment with immune checkpoint inhibitors, and first-line PFS\>7m Adebrelimab 1200 mg, iv. q3w Apatinib 250 mg po qd Lrinotecan liposome 80mg/m2, iv. q3w Continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.
  • Experimental: Previously not received immune checkpoint inhibitor treatment
    those who have received standard systemic chemotherapy Adebrelimab 1200 mg, iv. q3w Apatinib 250 mg po qd Lrinotecan liposome 80mg/m2, iv. q3w Continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.

Primary Outcome Measure

Progress Free Survival（PFS） [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months ]

Central Contacts

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