CompletedPhase 2

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

China40 participantsStarted 2021-01-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Retro-peritoneal lymph node metastasis (RPLM) (e.g. para-aortic, intra-aorto-caval, para-pancreatic or mesenteric lymph nodes).
✓. Single or bilateral Krukenberg tumors.
✓. No more than 5 liver metastases, and the maximum diameter of the lesions was less than 5 cm.
✓. Adrenal metastasis.
✓. Localized potentially operable peritoneal carcinomatosis: stage P1 according to classification of the"Japanese Research Society for Gastric Cancer (JRSCGC)".

What they're measuring

margin-free-(R0) resection rate

Timeframe: 6-9 weeks after immunochemotherapy

Trial details

NCT IDNCT04510064

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Metastatic Gastric Cancer trials