Camrelizumab Combined With Apatinib for Advanced Gastric or Esophagogastric Adenocarcinoma

NCT04948125 | Unknown Phase 2

• 1 other identifier: MA-GC-Ⅱ-011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase II study, to evaluate the effectiveness and safety of Camrelizumab combined with apatinib for advanced gastric or esophagogastric adenocarcinoma progressed after immune checkpoint inhibitors.

Conditions

Advanced Gastric Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  ORR was defined as the percentage of participants with best overall response of either CR or PR

  up to 1 years

Secondary Outcomes (5)

• Progression-Free Survival(PFS)

  up to 2 years

• Overall Survival (OS)

  up to 2.5 years

• Disease control rate(DCR)

  up to 1 years

• Time to progression(TTP)

  up to 2years

• Duration of response(DOR)

  up to 2years

Study Arms (1)

treatment group

EXPERIMENTAL

camrelizumab combined with apatinib

Drug: camrelizumab; Drug: Apatinib Mesylate

Interventions

camrelizumab DRUG

200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.

Also known as: SHR-1210

treatment group

Apatinib Mesylate DRUG

250 mg qd

treatment group

Eligibility Criteria

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

You may qualify if:

• The patient volunteered to participate in the study and signed an informed consent form；
• ≥18 years old; male or female
• confirmed incurable gastric and gastroesophageal junction adenocarcinoma（unresectable or metastatic) by pathological examination,at least have a measurable lesion without local treatment.(According to the RECIST V1.1,the long diameter of the lesion can be measured by spiral CT ≥10mm or the short diameter of the enlarged lymph nodes≥15mm;
• Adequate standard treatment was used in the past; At least two cycles of anti-PD-1 / PD-L1 / CTLA-4 antibody therapy and platinum based chemotherapy were used in the past; Imaging confirmed disease progression occurred during or within 12 weeks after the treatment with anti-PD-1 / PD-L1 / CTLA-4 antibody；
• It can provide the detection report of human epidermal growth factor receptor 2 (HER2); HER2 negative patients could be included in the study; HER2 positive patients who had failed to receive trastuzumab treatment in the past could be included in the study (HER2 positive was defined as ≥ 10% of tumor cells HER2 IHC 3 + or fish positive)；
• Swallowing pills normally；
• ECOG score: 0\~1 points;
• Expected survival period ≥ 12 weeks; A histological specimen can be provided for secondary testing;
• The main organ function meets the following criteria( It is not allowed to use any blood components or cell growth factor drugs within 14 days before the first medication）:
• The absolute value of neutrophils (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) \> 100 × 109 / L ；Albumin(ALB)≥ 90g / L;Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) ≤3 \* ULN; serum creatinine (Cr) ≤ 1.5 \* ULN ; Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if FT3 and FT4 levels are normal, they can be included in the group);Alkaline phosphatase（AKP)≤ 2.5 times the upper limit of normal (ULN).
• Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the end of the study; negative serum or urine pregnancy test within 72 hours prior to study enrollment and must be non-lactating patients; men should agree to patients who must use contraception during the study period and within 3 months after the end of the study period.

You may not qualify if:

• Any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo or asthma in childhood had complete remission and did not need any intervention in adulthood were included; Asthma requiring medical intervention with bronchodilators could not be included;
• Those who are using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose \> 10mg / day prednisone or other therapeutic hormones) and continue to use them within 2 weeks before entering the group;
• Severe allergic reaction to other monoclonal antibodies;
• Patients who end treatment due to related toxicity during anti-PD-1 / PD-L1 / CTLA-4 antibody treatment;
• Patients with known central nervous system metastasis (except patients with stable disease control and asymptomatic after four weeks of radiotherapy or surgery) or evidence of cancerous meningitis;
• Squamous or undifferentiated carcinoma of the stomach or gastroesophageal junction;
• The patients with ascites or pleural effusion with clinical symptoms who need puncture drainage or who have received pleural or ascites drainage within 2 weeks before randomization, except those who only showed a small amount of ascites or pleural effusion without clinical symptoms;
• Other malignant tumors in the past 3 years or at the same time (except for cured basal cell carcinoma of skin and carcinoma in situ of cervix);
• Patients with hypertension and cannot be well controlled after antihypertensive drug treatment (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg);
• There are clinical symptoms or diseases that can not be well controlled, such as: (1) heart failure of NYHA grade 2 or above (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmias need treatment or intervention (5) QTc \> 450ms (male); QTc \> 470ms (female);
• Low dose aspirin and low molecular weight heparin are allowed for prophylactic use in patients undergoing thrombolytic or anticoagulant therapy;
• In the first 3 months of randomization, there were significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, hemorrhagic gastric ulcer or vasculitis; If the fecal occult blood is still positive at baseline (except for weak positive and no clinical significance judged by the researcher), gastroscopy should be performed (the researcher can judge whether gastroscopy should be performed for those who have undergone total gastrectomy before). If the gastroscopy results indicate severe gastric ulcer or the risk of bleeding judged by the researcher, they can not be enrolled; Gastrointestinal perforation or fistula occurred within 3 months before randomization;
• The events of arteriovenous thrombosis occurred within 6 months before entering the group, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc;
• Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, etc.)
• Urine routine examination showed that urine protein was ≥ +, and 24-hour urine protein\> 1.0 g；

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital/The affiliated Cancer Hospital of ZhengZhou university

Henan, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; apatinib

Study Officials

• Ying Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Liu

CONTACT

13783604602; yaya7207@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: April 28, 2021
• Primary Completion: June 3, 2022
• Study Completion: August 3, 2023
• Last Updated: July 1, 2021

Record last verified: 2021-06

Locations

CN (1)