Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer

Conditions

• Gastric Cancer Stage IV

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• sintilimab — DRUG
  a checkpoint inhibitor via blocking PD-1 (programmed cell death-1) site of signaling.
• apatinib — DRUG
  a multi-target anti-angiogenic tyrosine kinase inhibitor (TKI)
• S1 — DRUG
  S-1 is an oral fluoropyrimidine consisting of tegafur (a prodrug that is converted to fluorouracil, mainly in liver microsomes but also in tumour tissue), gimeracil (an inhibitor of dihydropyrimidine dehydrogenase, which degrades 5-FU), and oteracil (which inhibits the phosphorylation of 5-FU in the gastrointestinal tract, thereby reducing the toxic effects of 5-FU in the intestinum).
• Nab paclitaxel — DRUG
  Nab paclitaxel is a albumin-bound well tolerated paclitaxel than traditional paclitaxel

Study Details

This is a single-arm, phase II study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of apatinib and two-drug chemotherapy (S-1 plus nab-paclitaxel) as conversion therapy in patients with stage IV gastric cancer in China.

Key Dates

Start date

May 1, 2019

Status verified

May 2023

Primary completion

Dec 1, 2022

Completion

Aug 30, 2023

Study Design

Enrollment

47 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: treatment
  Eligible patients will be given sintilimab(200mg iv, day 1), apatinib(250mg,once daily), S-1 (60mg, twice daily, day1-14) and nab-paclitaxel(without peritoneal metastases: 260 mg/m\^2 iv for 3h; with peritoneal metastases: 200mg/m\^2 iv plus 60mg/m\^2 ip; day 1) every 3 weeks for at least 3 cycles. The feasibility of surgery will be evaluated by a multidisciplinary team every 2-4 cycles. Patients assessed as inoperable will be allowed to continue maintenance therapy with the original regimen until disease progression or intolerable toxicity. For patients assessed as operable, apatinib will be discontinued and one more cycle of sintilimab combined with S-1 and nab-paclitaxel will be administered; radical surgery will be performed within 2-4 weeks after the end of treatment. Safety run-in stage will be set in the first 6 patients to determine the safety. The study will be terminated if dose-limiting toxicities (DLTs) occur in more than 2 patients.

Primary Outcome Measure

R0-surgery conversion rate [ Time Frame: up to one year ]