Camrelizumab Combined With Apatinib Versus Apatinib Alone in the Third-line Treatment of Metastatic Gastric Cancer

NCT ID: NCT05342389

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-11-01

Brief Summary

This is a study of Camrelizumab combined with Apatinib versus Apatinib alone in the third-line treatment of metastatic gastric cancer. Paticipants will be radomized to receive treatment of Camrelizumab combined with Apatinib or Apatinib alone. The primary study hypothesis is that the adding Camrelizumab to Apatinib can prolong the progressive-free survival of the paticipants.

Detailed Description

Camrelizumab 200mg intravenously 30 - 60 min biweekly; Apatinib mesylate 250mg or 500mg oral daily continuously; The treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurred.

Conditions

Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

A fixed dose of Camrelizumab 200mg will be administered intravenously (without preventive medication), and each infusion lasts 45min (no less than 30min, no more than 60min), once every two weeks; During the treatment period, 250 mg of Apatinib mesylate tablets will be taken orally daily continuously, and every 2 weeks is a treatment cycle. The treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurred.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

a PD-1 antibody

Apatinib Mesylate

Intervention Type: DRUG

an oral tyrosine kinase inhibitor

Control group

Apatinib mesylate tablets 500 mg will be taken orally daily continuously, every 2 weeks as a treatment cycle. Treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurs.

Group Type: ACTIVE_COMPARATOR

Apatinib Mesylate

Intervention Type: DRUG

an oral tyrosine kinase inhibitor

Interventions

Camrelizumab

a PD-1 antibody

Intervention Type: DRUG

Apatinib Mesylate

an oral tyrosine kinase inhibitor

Intervention Type: DRUG

Other Intervention Names

SHR-1210; Ai Tan

Eligibility Criteria

Inclusion Criteria

1. Male or female patients, age ≥ 18 years;

2. Patients with metastatic gastric cancer confirmed by histology or cytology;

3. Baseline blood routine and biochemical indicators meet the following criteria:

1) Hemoglobin ≥ 9.0 g/dL; 2) Absolute neutrophil count (ANC) ≥ 1,500/mm3; 3) Platelet count≥ 100,000/mm3; 4) Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); 5) Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 ULN; 6) The international standardized ratio of prothrombin time is ≤ 1.5, and part of the thromboplastin time is within the normal range (the lower limit of 1.2 times normal value to the upper limit of 1.2 times normal value); 7) Creatinine ≤ 1.5 ULN; 8) Urine protein <2+ (if urine protein ≥ 2+, then 24h urine protein quantitative protein must be ≤ 1g); 4．The presence of measurable lesions in patients; evaluated by investigators according to the Efficacy Evaluation Criteria (RECIST) v1.1 of Solid Tumors; 5．Eastern Tumor Collaboration Group Behavioral Status Score (ECOG PS) of 0 or 1; 6．Life expectancy ≥ 3 months; 7．The investigator assessed that the patient was able to comply with the protocol requirements; 8．Capable to sign the informed consent document.

Exclusion Criteria

1. Patients who have undergone systemic chemotherapy, radiation therapy, surgery, hormone therapy or immunotherapy in the 2 weeks prior to the screening;

2. Patients with a history of taking apatinib;

3. Patients with hypertension that is difficult to control despite having been treated with multiple antihypertensive drugs (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 90 mmHg);

4. Patients with acute coronary syndrome (including myocardial infarction and unstable angina) within 6 months prior to admission and a history of coronary angioplasty or stenting;

5. Patients with large pleural effusions or ascites requiring drainage;

6. According to NCI-CTCAE version 5.0, patients with ≥grade 3 active infections;

7. Patients with symptomatic brain metastases;

8. Patients with partial or complete gastrointestinal obstruction;

9. Patients with interstitial lung disease with symptoms or signs of activity;

10. Patients with allergies or hypersensitivity to therapeutic drugs, patients with autoimmune diseases, and have received allogeneic tissue/solid organ transplants;

11. Patients requiring systemic corticosteroids (excluding temporary use for trials, prophylactic administration for anaphylactic reactions or to reduce swelling associated with radiotherapy) or immunosuppressants, or patients who had received such therapy less than 14 days prior to admission to this study;

12. Patients with seizures who require medication;

13. Patients who undergo major surgery (open chest surgery or laparotomy, etc.), laparotomy biopsy, trauma within 28 days before registration. Registration can be carried out on the same day of the week preceding 4 weeks (however, if an artificial anastomosis is performed without bowel resection, it should be within 14 days prior to registration);

14. Patients with unhealed wounds, unhealed ulcers or unhealed fractures;

15. Patients with a history of allergies to any of the drugs studied, similar drugs or excipients;

16. Simultaneous reception of any other anti-tumor therapy, including anti-tumor proprietary Chinese medicines and immunochemicals;

17. Pregnant, lactating women, fertile but refusing to use contraception;

18. Other situations in which the investigators determined that they were not suitable for inclusion in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Xiao, PhD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

The Sixth Affiliated hosipital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Jian Xiao, PhD

Role: CONTACT

xiaoj26@mail.sysu.edu.cn

13711114566

Shanshan Li, MD

Role: CONTACT

lishsh38@mail.sysu.edu.cn

13450423491

Facility Contacts

Jian Xiao, PhD

Role: primary

13711114566

Other Identifiers

MA-II-GC-013

Identifier Type: -

Identifier Source: org_study_id