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

NCT05029453 | Unknown Phase 4 DMC

• 1 other identifier: PIONEER
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Randomized Controlled Study

Keywords

apatinib; chemotherapy; prior anti-PD-1 therapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival [PFS]

  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 Outcomes (5)

• Objective tumor response rate [ORR]

  1year

• disease control rate [DCR]

  1year

• Duration of response [DoR]

  1year

• overall survival [OS]

  3year

• Adverse Events [AEs]

  1year

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Gtoup

NO INTERVENTION

chemotherapy Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。

Interventions

Apatinib DRUG

In experimental group, the drug used with apatinib and chemotherapy.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0-1.
• 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.

You may not qualify if:

• 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
• 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)
• The patient has a serious or non healing wound or peptic ulcer or bone fracture;
• A patient with other malignancies within 3 years.
• patients whose adverse events (except hair loss) caused by previous treatment have not recovered to \<= CTCAE 1 degree;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Related Publications (11)

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  PMID: 29209523 BACKGROUND

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• Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.

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MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Tao Zhang, Doctor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Zhang, Doctor

CONTACT

（+86）18971656660; 1277577866@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of gastrointestinal oncology

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 31, 2021
• Study Start: August 26, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 3, 2023
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)