Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy

August 26, 2021 updated by: Tao Zhang, Wuhan Union Hospital, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tao Zhang, Doctor
  • Phone Number: （+86）18971656660
  • Email: 1277577866@qq.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: ≥18 years old, Female or Male;
  2. Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
  3. 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).
  4. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria
  5. ECOG performance status 0-1.
  6. An expected survival of > 12 weeks.
  7. Has adequate sufficient organ and bone marrow functions.
  8. 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.
  9. Fertile female subjects must undergo a serum-negative pregnancy test within 72 hours before starting the study drug
  10. 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:

  1. It is known that it's allergic to any test drug and its excipients.
  2. Previously received anti-angiogenic therapy, such as Ramucirumab and apatinib.
  3. patients with uncontrolled large amount of exudate [chest, pericardium, abdominal cavity]
  4. Patients with partial or complete gastrointestinal obstruction.
  5. Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
  6. Patients with uncontrolled clinical symptoms or diseases of the heart.
  7. 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.
  8. Long term use of aspirin, clopidogrel and other antiplatelet drugs, or warfarin and other anticoagulants;
  9. Received other therapy within 4 weeks.
  10. The patients who received systemic treatment with Chinese herbal medicine or immunomodulatory drugs
  11. According to the research's judgement, there are patients who seriously endanger the safety of patients or affect the patients who complete.(such as uncontrolled hypertension、diabetes、thyroid disease, etc)
  12. The patient has a serious or non healing wound or peptic ulcer or bone fracture;
  13. A patient with other malignancies within 3 years.
  14. patients whose adverse events (except hair loss) caused by previous treatment have not recovered to <= CTCAE 1 degree;
  15. The researchers considered unsuitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)。
Drug: Apatinib
In experimental group, the drug used with apatinib and chemotherapy.
No Intervention: Control Gtoup
chemotherapy Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective tumor response rate [ORR]
Time Frame: 1year
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
1year
disease control rate [DCR]
Time Frame: 1year
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）
1year
Duration of response [DoR]
Time Frame: 1year
Duration of response
1year
overall survival [OS]
Time Frame: 3year
OS is defined as the length of time from random assignment to death or to last contact.
3year
Adverse Events [AEs]
Time Frame: 1year
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Tao Zhang, Doctor, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 26, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

March 3, 2023

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIONEER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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