Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Last updated: April 19, 2023
Sponsor: Peking University
Overall Status: Active - Recruiting

Phase

2

Condition

Gastric Cancer

Digestive System Neoplasms

Stomach Cancer

Treatment

N/A

Clinical Study ID

NCT04609176
MA-GC-II-007
  • Ages > 18
  • All Genders

Study Summary

This is a study of Camrelizumab (SHR-1210) and Apatinb for unresectable Recurrent or metastatic alpha-fetoprotein (AFP)-producing gastric cancer or Gastroesophageal Junction Adenocarcinoma. Camrelizumab combined with Apatinib and standard chemotherapy will be given to treatment-naïve participants; Camrelizumab combined with Apatinib will also be evaluated in participants who have had ≥ 1 line of previous treatment. The primary endpoint is the Overall Response Rate (ORR).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who provided written informed consent to be subjects in this trial
  2. Aged ≥18 years
  3. Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG)Performance Scale
  4. Has histologically-confirmed diagnosis of locally advanced unresectable or metastaticgastric or GEJ adenocarcinoma
  5. Clinical staging was performed according to enhanced CT/MRI examination (combined withendoscopic ultrasonography and diagnostic laparoscopic exploration if necessary). Forpatients with locally advanced or metastatic gastric/GEJ cancer in stage III-IV (AJCC 8 edition TNM stage) that could not be resected, the possibility of resectable wasdetermined by MDT
  6. For cohort 1, no prior systemic chemotherapy for the treatment of the participant'sadvanced or metastatic disease (treatment with chemotherapy and/or radiation as partof neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 monthsprior to the diagnosis of advanced or metastatic disease); for cohort 2, received andprogressed on ≥1 prior systemic therapy for their advanced disease.
  7. Have measurable disease as defined by RECIST 1.1 as determined by investigatorassessment
  8. Serum AFP > 2 upper limit of normal (ULN) or AFP positive by immunohistochemicalstaining methods
  9. Adequate Organ Function Laboratory Values: Hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets ≥80×109/L;AST and ALT ≤ 2.5 ULN or ≤ 5 ULN for subjects with liver metastases; Total bilirubin ≤1.5 ULN; Serum creatinine ≤1.5 ULN or measured or calculated creatinine clearance > 50ml/min; Albumin ≥ 30g/L;
  10. No serious concomitant disease result in survival of less than 5 years
  11. Patients capable of taking oral medication
  12. Have good compliance and be able to follow the study protocol
  13. Female subjects of childbearing potential must have a negative urine or serumpregnancy test within 72 hours prior to receiving the first dose of study medicationand must be willing to use an adequate method of contraception for the course of thestudy through 90 days after the last dose of study medication. Male subjects ofchildbearing potential must agree to use an adequate method of contraception startingwith the first dose of study therapy through 90 days after the last dose of studytherapy
  14. Agree to provide blood and/or tumor tissue sample deemed adequate for PD-L1 and otherbiomarker analysis.

Exclusion

Exclusion Criteria:

  1. Is pregnant or breastfeeding
  2. HER2 positive subjects will be excluded from cohort 1
  3. Patients have recovered adverse events associated with pretreatment to Grade 1 orlower with CTCAE v5.0 excluding alopecia
  4. Patients have an active malignancy (except for definitively treated basal cellcarcinoma of the skin, or carcinoma-in-situ of the cervix) within the past 5 years
  5. Active heart disease that is not well controlled, e.g. symptomatic coronary heartdisease, New York Heart Association (NYHA) congestive heart failure of grade II orabove, severe arrhythmias requiring drug intervention, myocardial infarction withinthe past 12 months, QTc ≥ 450ms for male, QTc ≥ 450ms for female, LVEF<50%
  6. Genetic or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulationdisorders, thrombocytopenia, etc.)
  7. Patients with a history of gastrointestinal perforation, intra-abdominal abscess, orin-three-months ileus
  8. Coagulation disorders (International normalized ratio, INR > 2.0 or Prothrombin time,PT > 16s)
  9. Organ transplantation requires immunosuppressants, or who have receivedimmunosuppressants/systemic corticosteroids therapy <14 days before first dose for animmunosuppression purpose (> 10mg/day prednisone or other equivalency drugs)
  10. Patients have an active ulcer, serious non-healing wound, or bone fracture
  11. Patients with hypertension that is difficult to control (systolic blood pressure ≥140mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensiveagents
  12. Patients have a deficiency of dihydropyrimidine dehydrogenase (DPD) will be excludedfrom cohort 1
  13. Have any contraindications for study treatment
  14. Patients with a history of prior treatment with Apatinib or any anti-PD-1, anti-PD-L1agent
  15. Urinary protein is more than 2+ and 24-hour urine protein > 1.0g
  16. Patients with active hepatitis B (HBsAg positive and HBV DNA≥500 IU/ml), hepatitis C (HCV antibodies positive and HCV RNA copies > ULN); with active infection requiringdrug intervention
  17. Patients with active symptoms or signs of interstitial lung disease
  18. Patients with concurrent autoimmune disease, or a history of chronic or recurrentautoimmune disease
  19. Patients were judged unsuitable as subjects of this trial by investigators.

Study Design

Total Participants: 64
Study Start date:
November 18, 2020
Estimated Completion Date:
December 31, 2024

Study Description

This study will have 2 cohorts. In Cohort 1, participants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. In Cohort 2, participants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. A Simon two-stage phase II design was used for the sample size Calculation.

Connect with a study center

  • Peking University Cancer Hospital

    Beijing,
    China

    Active - Recruiting

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