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

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 6, 2021

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2024

Conditions
Metastatic Gastric CancerLocally Advanced Gastric AdenocarcinomaGastric Cancer Adenocarcinoma Metastatic
Interventions
DRUG

Camrelizumab plus mFLOT regimen

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.

PROCEDURE

R0 surgery

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.

Trial Locations (1)

210000

Fudan University, Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER

NCT04510064 - 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 | Biotech Hunter | Biotech Hunter