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

NCT05342389 | Unknown Phase 2

• 1 other identifier: MA-II-GC-013
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  the interval from randomization to tumor progression or death or the last follow-up

  1 year

Secondary Outcomes (4)

• Overall Survival

  2 years

• Objective response rate

  2 years

• Quality of Life assessed by EORTC QLQ-OG 25

  2 years

• Toxicity assessed by CTCAE V5.0

  2 years

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Drug: Camrelizumab; Drug: Apatinib Mesylate

Control group

ACTIVE COMPARATOR

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.

Drug: Apatinib Mesylate

Interventions

Camrelizumab DRUG

a PD-1 antibody

Also known as: SHR-1210

Experimental group

Apatinib Mesylate DRUG

an oral tyrosine kinase inhibitor

Also known as: Ai Tan

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, age ≥ 18 years;
• Patients with metastatic gastric cancer confirmed by histology or cytology;
• Baseline blood routine and biochemical indicators meet the following criteria:
• \) 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.

You may not qualify if:

• Patients who have undergone systemic chemotherapy, radiation therapy, surgery, hormone therapy or immunotherapy in the 2 weeks prior to the screening;
• Patients with a history of taking apatinib;
• 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);
• 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;
• Patients with large pleural effusions or ascites requiring drainage;
• According to NCI-CTCAE version 5.0, patients with ≥grade 3 active infections;
• Patients with symptomatic brain metastases;
• Patients with partial or complete gastrointestinal obstruction;
• Patients with interstitial lung disease with symptoms or signs of activity;
• Patients with allergies or hypersensitivity to therapeutic drugs, patients with autoimmune diseases, and have received allogeneic tissue/solid organ transplants;
• 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;
• Patients with seizures who require medication;
• 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);
• Patients with unhealed wounds, unhealed ulcers or unhealed fractures;
• Patients with a history of allergies to any of the drugs studied, similar drugs or excipients;

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated hosipital, Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Interventions

camrelizumab; apatinib

Study Officials

• Jian Xiao, PhD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Xiao, PhD

CONTACT

13711114566; xiaoj26@mail.sysu.edu.cn

Shanshan Li, MD

CONTACT

13450423491; lishsh38@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 22, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)