NCT04174339

PD-1 Antibody(SHR-1210) Plus Apatinib Combined With POF in Advanced Gastric Cancer

PD-1 Antibody(SHR-1210) Plus Apatinib Combined With POF in Treatment Naive Advanced Gastric Cancer: A Phase II Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single center, phase II study, to evaluate the effectiveness and safety of PD-1 Antibody(SHR-1210) Plus apatinib Combined With POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) , in the first-line treatment for patients with advanced/metastatic gastric cancer.

Detailed description

This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to compare that ORR of patients with camrelizumab plus apatinib and POF for advanced/metastatic gastric cancer. In treatment period, patients will be administrated camrelizumab plus apatinib and POF, every 28 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination. The imaging evaluation was performed according to the RECIST 1.1 criteria every 8 weeks.

Conditions

• Advanced Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial，d1
DRUG	Apatinib Mesylate	Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet，TID
DRUG	POF	The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.

Timeline

• Start date: 2019-12-10
• Primary completion: 2020-12-09
• Completion: 2021-05-02
• First posted: 2019-11-22
• Last updated: 2019-11-22

Locations

1 site across 1 country: China