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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Carrelizumab combined with XELOX
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wang NanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carrelizumab combined with XELOX

Arm Description

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

Outcomes

Primary Outcome Measures

pCR rate
Pathological remission rate according to Becker standard

Secondary Outcome Measures

MPR
major pathologic response according to Becker standard
DFS
disease-free survival
R0 resection rate
Proportion of R0 level surgery performed
OS
overall survival
ORR
Objective remission rate
Adverse reactions and perioperative complications (Security)
Adverse reactions and perioperative complications caused by drug therapy

Full Information

First Posted
December 21, 2022
Last Updated
July 13, 2023
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05715632
Brief Title
New Adjuvant Treatment of Locally Advanced Resectable Gastric Cancer With Carelizumab and XELOX
Official Title
Prospective, Single Arm, Single Center Exploratory Study on the New Adjuvant Therapy of Camrelizumab Combined With XELOX Regimen for Locally Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carrelizumab combined with XELOX
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Carrelizumab combined with XELOX
Intervention Description
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
Primary Outcome Measure Information:
Title
pCR rate
Description
Pathological remission rate according to Becker standard
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
MPR
Description
major pathologic response according to Becker standard
Time Frame
7 days after surgery
Title
DFS
Description
disease-free survival
Time Frame
Long term follow-up will continue until the death of the subject or the end of the study, at least three years
Title
R0 resection rate
Description
Proportion of R0 level surgery performed
Time Frame
postoperative 6 hours
Title
OS
Description
overall survival
Time Frame
Long term follow-up will continue until the death of the subject or the end of the study, at least three years
Title
ORR
Description
Objective remission rate
Time Frame
7 days after surgery
Title
Adverse reactions and perioperative complications (Security)
Description
Adverse reactions and perioperative complications caused by drug therapy
Time Frame
Long term follow-up will continue until the death of the subject or the end of the study, at least three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Wang, Dr
Phone
15719286297
Email
wangnandoc@163.com
Facility Information:
Facility Name
Wang Nan
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Wang, Dr
Phone
15719286297
Email
wangnandoc@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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