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

NCT04609176 | Unknown Phase 2

• 1 other identifier: MA-GC-II-007
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment

  ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.

  Up to approximately 24 months

Secondary Outcomes (9)

• Objective Response Rate (ORR) According to iRECIST 1.1 based on investigator assessment

  Up to approximately 24 months

• Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment

  Up to approximately 24 months

• Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment

  Up to approximately 24 months

• Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment

  Up to approximately 24 months

• Disease Control Rate (DCR) According to iRECIST 1.1 base on investigator assessment

  Up to approximately 24 months

Study Arms (2)

Camrelizumab+Apatinib+SOX

EXPERIMENTAL

Participants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. Camrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle.

Drug: Camrelizumab plus Apatinib and SOX

Camrelizumab+Apatinib

EXPERIMENTAL

Participants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle.

Drug: Camrelizumab plus Apatinib

Interventions

Camrelizumab plus Apatinib and SOX DRUG

Camrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle.

Camrelizumab+Apatinib+SOX

Camrelizumab plus Apatinib DRUG

Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle.

Camrelizumab+Apatinib

Eligibility Criteria

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

You may qualify if:

• Patients who provided written informed consent to be subjects in this trial
• Aged ≥18 years
• Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
• Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
• Clinical staging was performed according to enhanced CT/MRI examination (combined with endoscopic ultrasonography and diagnostic laparoscopic exploration if necessary). For patients 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 was determined by MDT
• For cohort 1, no prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to the diagnosis of advanced or metastatic disease); for cohort 2, received and progressed on ≥1 prior systemic therapy for their advanced disease.
• Have measurable disease as defined by RECIST 1.1 as determined by investigator assessment
• Serum AFP \> 2 upper limit of normal (ULN) or AFP positive by immunohistochemical staining methods
• 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;
• No serious concomitant disease result in survival of less than 5 years
• Patients capable of taking oral medication
• Have good compliance and be able to follow the study protocol
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication and must be willing to use an adequate method of contraception for the course of the study through 90 days after the last dose of study medication. Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy
• Agree to provide blood and/or tumor tissue sample deemed adequate for PD-L1 and other biomarker analysis.

You may not qualify if:

• Is pregnant or breastfeeding
• HER2 positive subjects will be excluded from cohort 1
• Patients have recovered adverse events associated with pretreatment to Grade 1 or lower with CTCAE v5.0 excluding alopecia
• Patients have an active malignancy (except for definitively treated basal cell carcinoma of the skin, or carcinoma-in-situ of the cervix) within the past 5 years
• Active heart disease that is not well controlled, e.g. symptomatic coronary heart disease, New York Heart Association (NYHA) congestive heart failure of grade II or above, severe arrhythmias requiring drug intervention, myocardial infarction within the past 12 months, QTc ≥ 450ms for male, QTc ≥ 450ms for female, LVEF\<50%
• Genetic or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.)
• Patients with a history of gastrointestinal perforation, intra-abdominal abscess, or in-three-months ileus
• Coagulation disorders (International normalized ratio, INR \> 2.0 or Prothrombin time, PT \> 16s)
• Organ transplantation requires immunosuppressants, or who have received immunosuppressants/systemic corticosteroids therapy \<14 days before first dose for an immunosuppression purpose (\> 10mg/day prednisone or other equivalency drugs)
• Patients have an active ulcer, serious non-healing wound, or bone fracture
• Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents
• Patients have a deficiency of dihydropyrimidine dehydrogenase (DPD) will be excluded from cohort 1
• Have any contraindications for study treatment
• Patients with a history of prior treatment with Apatinib or any anti-PD-1, anti-PD-L1 agent
• Urinary protein is more than 2+ and 24-hour urine protein \> 1.0g

Sponsors & Collaborators

• Peking University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Peking University Cancer Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Wang Y, Lu J, Chong X, Wang C, Chen X, Peng Z, Gu Y, Wang Y, Wang X, Li J, Gong J, Qi C, Yuan J, Lu Z, Lu M, Zhou J, Cao Y, Chen Y, Zhang C, Hou Z, Kou H, Shen L, Zhang X. PD-1 antibody camrelizumab plus apatinib and SOX as first-line treatment in patients with AFP-producing gastric or gastro-esophageal junction adenocarcinoma (CAP 06): a multi-center, single-arm, phase 2 trial. Signal Transduct Target Ther. 2025 Mar 14;10(1):100. doi: 10.1038/s41392-025-02193-z.

  PMID: 40082418 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Xiaotian Zhang

CONTACT

86-10-88196175; zhangxiaotianmed@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 17, 2020
• First Posted: October 30, 2020
• Study Start: November 18, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

CN (1)