A Prospective, Multicenter, Randomized Controlled Study of Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy

Wuhan Union Hospital, China1 site in 1 country60 target enrollmentAugust 26, 2021

ConditionsGastric Cancer Randomized Controlled Study

InterventionsApatinib

DrugsApatinib

Overview

Phase: Phase 4
Intervention: Apatinib
Conditions: Gastric Cancer
Sponsor: Wuhan Union Hospital, China
Enrollment: 60
Locations: 1
Primary Endpoint: Progression Free Survival [PFS]
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a multicenter, open-label, randomized controlled clinical study. The purpose of the study is to evaluate the efficacy and safety of apatinib combined with chemotherapy versus chemotherapy in second-line gastric cancer receiving prior anti-PD-1 therapy.

Detailed Description

60 patients who meet the inclusion criteria will receive apatinib combine with chemotherapy or chemotherapy until the disease progresses or intolerable. Apatinib: initial dose: 500mg,oral,once a day, after meal (try to take the medicine at the same time each day)

Registry

clinicaltrials.gov

Start Date

August 26, 2021

End Date

March 3, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wuhan Union Hospital, China

Responsible Party

Principal Investigator

Tao Zhang

Chief of gastrointestinal oncology

Wuhan Union Hospital, China

Eligibility Criteria

Inclusion Criteria

•Age: ≥18 years old, Female or Male;
•Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
•Failure or intolerance of first-line chemotherapy which requires that the first-line chemotherapy regimen include the scheme based on anti-PD-1 drugs for no less than 2 months (Definition of treatment failure: intolerence of toxic side effects; disease progression during treatment; Or recurrence after the end of treatment.) Note: (1)The treatment of each line advanced disease includes one or more drugs with a medication time ≥ 1 cycle. (2) Early adjuvant/neo-adjuvant therapy is allowed. If recurrence occurs during adjuvant/neoadjuvant therapy or within ≤24 weeks after completion, adjuvant/neoadjuvant therapy is considered to be a first-line pre-systemic chemotherapy for advanced disease. (3) Early-stage immunotherapy, combined chemotherapy or combined targeted drugs are allowed (except for VEGFR inhibitors).
•Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria
•ECOG performance status 0-
•An expected survival of \> 12 weeks.
•Has adequate sufficient organ and bone marrow functions.
•Patients whose adverse events caused by previous treatment have recovered to \<= CTCAE 1 degree; And the interval between receiving nitroso or mitomycin ≥6 weeks; Receiving other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has healed completely.
•Fertile female subjects must undergo a serum-negative pregnancy test within 72 hours before starting the study drug
•Patients have agreed and signed the informed consent. Willingness and able to follow the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion Criteria

•It is known that it's allergic to any test drug and its excipients.
•Previously received anti-angiogenic therapy, such as Ramucirumab and apatinib.
•patients with uncontrolled large amount of exudate \[chest, pericardium, abdominal cavity\]
•Patients with partial or complete gastrointestinal obstruction.
•Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
•Patients with uncontrolled clinical symptoms or diseases of the heart.
•In the first 3 months of the study, patients who had significant clinical bleeding symptoms or had definite bleeding tendency; History of gastrointestinal perforation and/or fistulae within 6 months prior to medications.
•Long term use of aspirin, clopidogrel and other antiplatelet drugs, or warfarin and other anticoagulants;
•Received other therapy within 4 weeks.
•The patients who received systemic treatment with Chinese herbal medicine or immunomodulatory drugs

Arms & Interventions

Experimental Group

apatinib combine with chemotherapy. Apatinib: initial dose: 500mg,oral,once a day, after meal ( try to take the medicine at the same time each day) Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。

Intervention: Apatinib

Outcomes

Primary Outcomes

Progression Free Survival [PFS]

Time Frame: 36 months

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months