Conversion Effects of PD-1 Antibody Camrelizumab Combined With Nab-POF Regimen Chemotherpy in Patients With Initially Unresectable Locally Advanced or Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma：FDZL-GC001 Trial

Sponsor
Fudan University
Study ID
NCT04510064
Phase
PHASE2
Status
Completed

Conditions

  • Gastric Cancer Adenocarcinoma Metastatic
  • Locally Advanced Gastric Adenocarcinoma
  • Metastatic Gastric Cancer

Eligibility Criteria

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

Interventions

  • Camrelizumab plus mFLOT regimen — DRUG
    Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every three weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed.
  • R0 surgery — PROCEDURE
    The efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity.

Study Details

This study is to evaluate the efficacy and safety of domestic programmed death 1（ PD-1） antibody (Camrelizumab for injection) combined with fluorouracil plus leucovorin, oxaliplatin, and albumin bound paclitaxel (Nab-POF) regimen in the treatment of patients with unresectable locally advanced or limited metastatic gastric cancer. The primary efficacy endpoint is R0 resection rate.

Key Dates

Start date
Jan 6, 2021
Status verified
Mar 2025
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every two weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed.The efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity.

Primary Outcome Measure

margin-free-(R0) resection rate [ Time Frame: 6-9 weeks after immunochemotherapy ]

Related Studies