Camrelizumab Combined With FOLFOX Neoadjuvant Therapy for Resectable Gastric and Gastroesophageal Junctional Adenocarcinoma

NCT03939962 | Unknown Phase 2

• 1 other identifier: HNGC-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ，the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• R0 resection rate

  The percentage of patients who have no residual cancer cells (gross or microscopically) at the resection margins.

  Up to approximately 16 weeks

• pathological complete response (pCR) rate

  The percentage of patients with no residual cancer cells at the primary cancer site and N(-) per histological evaluation.

  Up to approximately 16 weeks

Secondary Outcomes (5)

• Near pathological complete response (near-pCR) rate

  Up to approximately 16 weeks

• Overall survival(OS)

  From randomization to the date of death (up to approximately 4 years)

• Progression-free survival(PFS)

  up to 2 years

• Disease-free survival (DFS)

  From randomization to the date of recurrence or death (up to approximately 4 years)

• Percentage of Participants Who Experience One or More Adverse Events (AEs)

  up to approximately 1 years

Study Arms (1)

treatment group

EXPERIMENTAL

Neoadjuvant therapy:SHR1210 combined with FOLFOX repeat every 14 days for a total of 4 cycles. Adjuvant therapy:SHR1210 combined with chemotherapy (the specific regimen will be chosen at the discretion of the investigator), every 14 days for a total of 4 cycles. After that, the patients will receive camrelizumab monotherapy for up to 1 year (from the first SHR1210 treatment).

Drug: SHR1210 combined with FOLFOX

Interventions

SHR1210 combined with FOLFOX DRUG

1. SHR1210, iv, 200 mg d1, 30-minute intravenous infusion, repeated every 14 days. 2. FOLFOX: Oxaliplatin 85mg/m2 ivgtt 2h d1; 5-fluorouracil 400mg/m2 iv d1; leucovorin 400mg/m2 ivgtt 2h d1,5-fluorouracil 2400mg/m2 CIV 46h, repeated every 14 days Patients who have no disease progression and can tolerate surgery receive surgery. When the investigator believes that the patient is not suitable for continued medication or according to the RECIST 1.1 standard, the evaluation is PD and the medication is over. The PD-1 monoclonal antibody does not allow for reductions and can only delay or suspend medication.

treatment group

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old; male or female
• confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination
• Imaging (CT/MRI) and ultrasound gastroscopy confirmed: cT ≥ T2 and / or regional lymph node positive (N +);
• ECOG score: 0\~2 points;
• Expected survival period ≥ 12 weeks;
• A histological specimen can be provided for secondary testing;
• The main organ function meets the following criteria within 7 days before treatment:
• Blood routine examination criteria (without blood transfusion within 14 days):
• Hemoglobin (HB) ≥ 90g / L; The absolute value of neutrophils (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) ≥ 80 × 109 / L (2) Biochemical examinations must meet the following criteria: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) ≤ 2.5 \* ULN; serum creatinine (Cr) ≤ 1.5 \* ULN or creatinine clearance (CCr) ≥ 60ml / min; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
• Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days 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 6 months after the end of the study period.
• The patient volunteered to participate in the study and signed an informed consent form;

You may not qualify if:

• Exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (in situ carcinoma) And T1 (tumor infiltrating basement membrane)\];
• Patients with a high risk of bleeding or fistula due to the apparent invasion of adjacent organs (aorta or trachea);
• Before starting treatment， subject administrated corticosteroids (day\> 10 mg equivalent dose prednisone), or other immunosuppressive drugs for systemic treatment of a disease within 14 days . In the absence of active autoimmune disease, \>10 mg of daily prednisone equivalent dose of inhaled or topical steroid and adrenal replacement steroid doses are permitted;
• Anyone who has received any anti-tumor treatment in the past;
• Participants who received live/attenuated vaccine within 30 days of the first treatment;
• Unresolved toxicity due to any previous treatment above CTC AE4.0 Level 2, excluding neurotoxicity of ≤2 caused by hair loss and oxaliplatin;
• Allergic reactions and adverse drug reactions:
• a history of allergies to the ingredients of the study drug;
• contraindications to any study drug (fluorouracil or oxaliplatin) in the chemotherapy regimen.
• Patients with any severe and/or uncontrolled disease, including:
• patients with hypertension who are not well controlled by antihypertensive drug (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg);
• with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification);
• Severe or uncontrolled disease or active infection (≥CTCAE grade 2 infection), which the investigator believes may increase the risk associated with study participation, study drug administration, or affect the subject's ability to receive study medication;
• Renal failure requires hemodialysis or peritoneal dialysis;
• a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, 450008, China

Location

Related Publications (1)

• Zhao Y, Li D, Zhuang J, Li Z, Xia Q, Li Z, Yu J, Wang J, Zhang Y, Li K, Xu S, Li S, Ma P, Cao Y, Liu C, Xu C, Liu Z, Wei J, Zhang C, Qiao L, Gao X, Hou Z, Liu C, Zheng R, Wang D, Liu Y. Comprehensive multi-omics analysis of resectable locally advanced gastric cancer: Assessing response to neoadjuvant camrelizumab and chemotherapy in a single-center, open-label, single-arm phase II trial. Clin Transl Med. 2024 May;14(5):e1674. doi: 10.1002/ctm2.1674.

  PMID: 38685486 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

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

Study Officials

• Ying Liu

  Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 7, 2019
• Study Start: July 24, 2019
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2024
• Last Updated: January 26, 2022

Record last verified: 2021-05

Locations

CN (1)