Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer

NCT05545436 | Unknown Phase 2

• 1 other identifier: （2022）02-181-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open, exploratory clinical study to evaluate the efficacy of carrelizumab (PD-1) combined with chemotherapy (SOX/XELOX) as neoadjuvant therapy and to observe the changes of tumor immune microenvironment in patients with locally advanced gastric or gastroesophageal junction cancer (T3-4NXM0).

Conditions

Locally Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR, Becker criteria, TRG 1A)

  It was evaluated according to tumor regression grade (Becker standard) : TRG1a had no residual cancer; TRG1b \< 10% residual cancer; TRG2 10%-50% residual cancer; TRG3 \> 50% residual cancer.

  Up to approximately 6 months.

Secondary Outcomes (2)

• Major pathological response rate (MPR, TRG1a/ B)

  Up to approximately 6 months.

• R0 resection rate and objective response rate (ORR, RECIST 1.1)

  Up to approximately 6 months.

Study Arms (1)

Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )

EXPERIMENTAL

Camrelizumab + SOX / XELOX

Drug: Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )

Interventions

Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) DRUG

Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) Drug: Camrelizumab 200mg Drug: oxaliplatin 130 mg/m2 Drug: Teggio 40 mg/m2 Drug: oxaliplatin 130 mg/m2 Drug: capecitabine 1000 mg/m2 Q3W for 3 cycles. Radical surgery was performed 3 weeks after the last neoadjuvant treatment.

Also known as: Camrelizumab + SOX / XELOX

Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T3-4NxM0 locally advanced gastric or gastroesophageal junction carcinoma was confirmed by gastroscopic biopsy, CT and pathological examination;
• No previous systematic treatment for the current disease;
• Age ≥ 70 years, age ≥18 years, both sexes;
• ECOG physical status score 0-1; Full organ and bone marrow function:
• Blood routine: hemoglobin ≥90g/L, neutrophil count ≥1.5×10\^9/L, platelet count ≥75×10\^9/L; Liver function: serum total bilirubin ≤1.5× upper normal value (UNL), aspartate transferase ≤3×UNL, alanine Acid transferase ≤3×UNL; Renal function: serum creatinine ≤1.5×UNL, creatinine clearance rate ≥50ml/min; Coagulation function: INR, APTT and PT ≤1.5×UNL; Serum albumin ≥30g/L; Thyrotropin (TSH) and free thyroxine (fT4) were within the range of normal ±10%.
• Electrocardiogram showed no obvious abnormality.
• Not receiving blood transfusion, blood products, or blood cell growth factors such as granulocyte colony-stimulating factor within 2 weeks;
• Sign an informed consent form before starting the study on a specific screening procedure;
• The estimated survival time is more than 3 months;
• Subjects volunteered to join this study, with good compliance, safety and survival follow-up -

You may not qualify if:

• Patients with any of the following were excluded from the study:
• People with allergic disease, history of severe drug allergy, known allergy to macromolecular protein preparations or carrelizumab;
• Early gastric cancer;
• Gastric cancer patients with HER2 amplification by pathological gene detection;
• History of other malignancies (except cured basal cell carcinoma of the skin, cured cervix) with disease-free survival \<5 years Carcinoma in situ and gastrointestinal neoplasms proven to be cured by endoscopic mucosal resection);
• The presence or history of any active autoimmune disease (including but not limited to: interstitial pneumonia, Uveitis, enteritis, nephritis, hyperthyroidism, hypothyroidism);
• You are using immunosuppressive agents or hormone therapy (systemic or topical) to achieve immunosuppression, and Continued to use within 2 weeks before enrollment;
• Severe infection (if intravenous antibiotics, antifungal or antiviral drugs are needed);
• Congenital or acquired immune deficiency (such as HIV-infected persons), or active hepatitis ((with regular antiviral treatment)

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; Oxaliplatin; XELOX; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Hongbo Wei, M.D., Ph.D.

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbo Wei, M.D., Ph.D.

CONTACT

86-13060620467; drweihb@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of Gastrointestinal Surgery

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 19, 2022
• Study Start: September 20, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

CN (1)