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

Sponsor
Fujian Cancer Hospital
Study ID
NCT04174339
Status
Unknown

Conditions

  • Advanced Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial，d1
  • Apatinib Mesylate — DRUG
    Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet，TID
  • POF — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 10, 2019
Status verified
Oct 2019
Primary completion
Dec 9, 2020
Completion
May 2, 2021

Study Design

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

Arms

  • Experimental: camrelizumab plus apatinib and POF
    Participants will receive camrelizumab in combination with apatinib plus POF until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Primary Outcome Measure

Objective response rate(ORR) [ Time Frame: From enrollment to 12 month ]

Central Contacts

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