New Adjuvant Treatment of Locally Advanced Resectable Gastric Cancer With Carelizumab and XELOX

Prospective, Single Arm, Single Center Exploratory Study on the New Adjuvant Therapy of Camrelizumab Combined With XELOX Regimen for Locally Advanced Gastric Cancer

To evaluate the efficacy and safety of carelizumab combined with XELOX regimen in neoadjuvant treatment of locally advanced resectable gastric cancer

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Carrelizumab combined with XELOX

Detailed Description

This study is a prospective, single center, single arm clinical study. This study plans to include 67 patients with locally advanced gastric adenocarcinoma who can be operated without any treatment as the study object. After signing the informed consent, they are screened to meet the inclusion criteria. After receiving the standard dose of karelizumab combined with XELOX regimen for 4 courses of treatment before surgery, and within 3-4 weeks after the completion of the fourth administration, preoperative imaging examination is used to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, The patient received radical surgical treatment for gastric cancer, and continued to receive adjuvant treatment of the original scheme after the operation (the first treatment started 6 weeks ± 2 weeks after the operation, and can not exceed 3 months).

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nan Wang, Dr; Phone Number: 15719286297; Email: wangnandoc@163.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710038
      • Recruiting
      • Wang Nan
      • Contact: Nan Wang, Dr; Phone Number: 15719286297; Email: wangnandoc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sign the written informed consent before implementing any test related process
• Endoscopic or enhanced CT /MRI scanning (combined with ultrasonic gastroscopy and diagnostic laparoscopic exploration if necessary) cTNM was diagnosed as cT3-4aN1-3M0, and the investigator assessed that the lesion was resectable;
• Have not received systematic treatment for current diseases in the past, including surgical treatment, anti-tumor radiotherapy and chemotherapy /immunotherapy;
• Patients who agree to receive radical surgical treatment and have no surgical contraindication as judged by the surgeon
• ECOG score 0-1;
• The expected survival time is more than 6 months;
• Female subjects of childbearing age should receive urine or serum pregnancy test within 3 days before receiving the first study drug (the first day of the first cycle) and the result is negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non childbearing age are defined as those who have had at least one year after menopause, or who have undergone surgical sterilization or hysterectomy;
• If there is a risk of pregnancy, all subjects (male or female) should use contraceptives with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration)

Exclusion Criteria:

• Other malignant diseases (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and /or carcinoma in situ after radical resection) diagnosed within 5 years before the first administration;
• Known endoscopic signs of active hemorrhage of the lesion;
• Currently participating in the intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
• Have received the following therapies in the past: anti PD-1, anti PD-L1 or anti PD-L2 drugs or drugs targeting another kind of stimulation or synergistic inhibition of T cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.);
• Within 2 weeks before the first administration, he has received systematic systemic treatment with Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion);
• Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological glucocorticoid for adrenal or pituitary insufficiency) is not considered as systemic therapy;
• The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration;
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• People known to be allergic to the drugs used in this study;
• People with multiple factors affecting capecitabine (such as inability to swallow and intestinal obstruction);
• Before starting treatment, the patient has not fully recovered from the toxicity and/or complications caused by any intervention (i.e. ≤ Level 1 or reaching the baseline, excluding fatigue or hair loss);
• Known history of human immunodeficiency virus (HIV) infection (i.e. HIV /2 antibody positive);
• Untreated active hepatitis B ；
• Active HCV infected subjects；
• Live vaccine shall be inoculated within 30 days before the first administration (the first cycle, the first day);
• Pregnant or lactating women;
• Abnormal medical history or disease evidence, treatment or laboratory test value that may interfere with the test results, prevent the subject from participating in the study in the whole process, or other conditions that the researcher believes are not suitable for inclusion. The researcher believes that there are other potential risks that are not suitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Carrelizumab combined with XELOX; Before surgery, the patient received standard dose of Carrelizumab combined with XELOX regimen for 4 courses of treatment, and within 3-4 weeks after the completion of the fourth administration, preoperative imaging examination was conducted to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, and to receive radical surgery for gastric cancer

Drug: Carrelizumab combined with XELOX; Before surgery, the patient received standard dose of carrelizumab combined with XELOX regimen for 4 courses of treatment, and within 3-4 weeks after the completion of the fourth administration, preoperative imaging examination was conducted to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, and to receive radical hand surgery for gastric cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR rate	Pathological remission rate according to Becker standard	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPR	major pathologic response according to Becker standard	7 days after surgery
DFS	disease-free survival	Long term follow-up will continue until the death of the subject or the end of the study, at least three years
R0 resection rate	Proportion of R0 level surgery performed	postoperative 6 hours
OS	overall survival	Long term follow-up will continue until the death of the subject or the end of the study, at least three years
ORR	Objective remission rate	7 days after surgery
Adverse reactions and perioperative complications (Security)	Adverse reactions and perioperative complications caused by drug therapy	Long term follow-up will continue until the death of the subject or the end of the study, at least three years

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 202108-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No