Clinical trial NCT04267549: Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer
Official title: Efficacy and Safety of Conversion Therapy With Sintilimab in Combination With Chemotherapy and Apatinib in Patients With Stage IV Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer Stage IV
Keywords: PD-1 inhibitor
conversion therapy
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: eligible patients will be given treatment of sintilimab, apatinib and chemotherapy (nab-paclitaxel) every 3 weeks
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* gastric adenocarcinoma confirmed by gastroscopy and pathology (histologically/cytologically ) ;
* life expectancy of ≥3-month；
* unresectable patients who were initially diagnosed as stage IV (clinical stage, American Joint Committee on Cancer 8th edition);
* Eastern Cooperative Oncology Group performance status: 0-1;
* must have at least 1 of the following unresectable factors indicated by CT, MRI or positron emission tomography(PET)-CT:

  1. N3 lymphatic metastasis;
  2. Extensive or bulky lymph nodes;
  3. T4b;
  4. Hepatic metastasis: ≤5 lesions, total diameter of ≤8cm;
  5. Peritoneal metastasis (CY1, P1);
  6. Kukernburg tumor;
* adequate organ function;
* pregnant test negative of females of childbearing potential , and willing to use adequate contraception;
* written Informed Consensus Form;

Exclusion Criteria:

* prior use of any checkpoint inhibitor treatment, including PD-1, programmed cell death ligand-1(PDL-1), CTLA4 etc;
* Her-2 positive with willing to use herceptin treatment;
* prior active autoimmune disease or history of autoimmune disease;
* clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class \> 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) \< 50%;
* not controlled hypertension;
* prior systemic treatment to metastatic disease；
* previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency;
* history of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis ;
* patients who may receive vaccination during study period;
* mental disorders history, or psychotropic drug abuse history;
* unable to orally administration;

Primary outcomes:
measure: R0-surgery conversion rate
timeFrame: up to one year
Secondary outcomes:
measure: objective response rate (ORR)
timeFrame: up to one year
measure: disease control rate (DCR)
timeFrame: up to one year
measure: conversion rate
timeFrame: up to one year
measure: overall survival (OS)
timeFrame: up to two years
measure: event-free survival (EFS)
timeFrame: up to two years
measure: Treatment-Related Adverse Events (TRAEs)
timeFrame: from the first day of treatment until 1 month after the end of treatment
measure: surgery-related complications
timeFrame: from the day of surgery to 30 days postoperatively
Other outcomes:
measure: pathological response
timeFrame: up to one year after surgery
Locations:
city: Tianjin
country: China
facility: Department of Gastric Surgery, Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: