A Clinical Study of Adebrelimab Combined With Apatinib and Paclitaxel in Patients With Advanced Gastric Cancer.

Sponsor
Chinese PLA General Hospital
Study ID
NCT06339216
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab+Apatinib+Paclitaxel for Injection(Albumin Bound) — DRUG
    Adebrelimab injection：Intravenous infusion, fixed dose 1200 mg, Day 1, Q3W. Until disease progression or intolerable toxicity occurs, the infusion should be administered over 30 to 60 minutes and over a maximum of 2 hours. When adalimumab is administered in combination with chemotherapy, Adebrelimab should be administered as an intravenous infusion first, followed by chemotherapy at least 30 minutes apart. Apatinib mesylate：Administered orally, 250 mg/time, once daily, orally, half an hour after meals (the time of daily administration should be as same as possible), with warm boiled water, the missed dose of Apatinib during the course of treatment cannot be supplemented. Paclitaxel for Injection(Albumin Bound)：Intravenous infusion, 250 mg/m2, day 1, Q3W, intravenous drip over 30 minutes.

Study Details

Phase II Clinical Study of Adebrelimab Combined with Apatinib and Paclitaxel for Injection(Albumin Bound) as Second-line Therapy in Patients with Advanced Gastric Cancer Previously Treated with Immunotherapy

Key Dates

Start date
Mar 20, 2024
Status verified
Mar 2024
Primary completion
Dec 30, 2024
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab+Apatinib+Paclitaxel for Injection(Albumin Bound)
    Adebrelimab injection was started on Day 1 of each cycle, followed 30 minutes later by intravenous drip of Paclitaxel for Injection(Albumin Bound). Combined treatment for 6 to 8 weeks, after efficacy evaluation, the investigator decides the subsequent treatment regimen, or until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of informed consent, or the investigator judges that the subject needs to withdraw from the study treatment. Following RECISTv1.1 defined progression (as assessed by the investigator), study drug may continue if the investigator assesses that the subject is still receiving clinical benefit and tolerates study treatment.

Primary Outcome Measure

ORR [ Time Frame: up to 3 years ]

Central Contacts

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