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

Last updated: August 26, 2021
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Not Recruiting

Phase

4

Condition

Gastric Cancer

Digestive System Neoplasms

Stomach Cancer

Treatment

N/A

Clinical Study ID

NCT05029453
PIONEER
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-linechemotherapy regimen include the scheme based on anti-PD-1 drugs for no less than 2months (Definition of treatment failure: intolerence of toxic side effects; diseaseprogression during treatment; Or recurrence after the end of treatment.) Note: (1)Thetreatment of each line advanced disease includes one or more drugs with a medicationtime ≥ 1 cycle. (2) Early adjuvant/neo-adjuvant therapy is allowed. If recurrenceoccurs during adjuvant/neoadjuvant therapy or within ≤24 weeks after completion,adjuvant/neoadjuvant therapy is considered to be a first-line pre-systemicchemotherapy for advanced disease. (3) Early-stage immunotherapy, combinedchemotherapy 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; Receivingother cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has healedcompletely.
  9. Fertile female subjects must undergo a serum-negative pregnancy test within 72 hoursbefore starting the study drug
  10. Patients have agreed and signed the informed consent. Willingness and able to followthe planned visit, research treatment, laboratory examination and other testprocedures.

Exclusion

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, abdominalcavity]
  4. Patients with partial or complete gastrointestinal obstruction.
  5. Hypertension, which cannot be well controlled by antihypertensive drugs (systolicblood 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 bleedingsymptoms or had definite bleeding tendency; History of gastrointestinal perforationand/or fistulae within 6 months prior to medications.
  8. Long term use of aspirin, clopidogrel and other antiplatelet drugs, or warfarin andother anticoagulants;
  9. Received other therapy within 4 weeks.
  10. The patients who received systemic treatment with Chinese herbal medicine orimmunomodulatory drugs
  11. According to the research's judgement, there are patients who seriously endanger thesafety of patients or affect the patients who complete.(such as uncontrolledhypertension、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 notrecovered to <= CTCAE 1 degree;
  15. The researchers considered unsuitable for inclusion.

Study Design

Total Participants: 60
Study Start date:
August 26, 2021
Estimated Completion Date:
March 03, 2023

Study 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)

Connect with a study center

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

    Wuhan, Hubei 430022
    China

    Site Not Available

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