A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
camrelizumab+chemotherapy
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, neoadjuvant chemotherapy, immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
- Male or female patients between the ages of 18-75;
- Patients diagnosed as gastric adenocarcinoma by histology or cytology;
- Stage: Locally advanced stage (T3-4aN1-3M0);
- Have not received other immunotherapy drugs or chemotherapy drugs in the past;
- ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
- Has sufficient organ and bone marrow function
Exclusion Criteria:
- Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
- A distant metastasis occurs;
- Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
- Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
- Patients with any severe and/or uncontrollable disease;
- Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
- Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
- Received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping;
- Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
- Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
- Participated in other anti-tumor drug clinical trials within four weeks;
- According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
- Female patients who are pregnant or breastfeeding;
- Known hypersensitivity to any study drug.
Sites / Locations
- Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
camrelizumab+chemotherapy
chemotherapy
Arm Description
neoadjuvant treatment with camrelizumab+chemotherapy
neoadjuvant treatment with chemotherapy
Outcomes
Primary Outcome Measures
major pathologic response rate
complete or subtotal regression (<10% residual tumor per tumor bed)
Secondary Outcome Measures
complete pathologic response rate
complete regression (no residual tumor per tumor bed)
R0 resection rate
surgically removed tissue without residual cancer cells
Overall survival
the time from the start of randomization to death due to any cause.
Disease-free survival
the time from the start of randomization to the incurable resection, local recurrence or metastasis, or death from any cause.
perioperative complications
perioperative complications
Full Information
NCT ID
NCT05101616
First Posted
October 28, 2021
Last Updated
August 9, 2022
Sponsor
Shanghai Minimally Invasive Surgery Center
1. Study Identification
Unique Protocol Identification Number
NCT05101616
Brief Title
A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer
Official Title
A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer: a Single-center, Open-label, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Minimally Invasive Surgery Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, neoadjuvant chemotherapy, immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
camrelizumab+chemotherapy
Arm Type
Experimental
Arm Description
neoadjuvant treatment with camrelizumab+chemotherapy
Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
neoadjuvant treatment with chemotherapy
Intervention Type
Drug
Intervention Name(s)
camrelizumab+chemotherapy
Intervention Description
camrelizumab 200mg,ivdrip,q3w; albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip,d1,q3w; oxaliplatine 85mg/m2、ivdrip,d1,q3w; S-1 40 mg/m2,po, bid,d1~d14,q3w. 3 cycles.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip,d1,q3w; oxaliplatine 85mg/m2、ivdrip,d1,q3w; S-1 40 mg/m2,po, bid,d1~d14,q3w. 3 cycles.
Primary Outcome Measure Information:
Title
major pathologic response rate
Description
complete or subtotal regression (<10% residual tumor per tumor bed)
Time Frame
one month after surgery
Secondary Outcome Measure Information:
Title
complete pathologic response rate
Description
complete regression (no residual tumor per tumor bed)
Time Frame
one month after surgery
Title
R0 resection rate
Description
surgically removed tissue without residual cancer cells
Time Frame
one month after surgery
Title
Overall survival
Description
the time from the start of randomization to death due to any cause.
Time Frame
3 years
Title
Disease-free survival
Description
the time from the start of randomization to the incurable resection, local recurrence or metastasis, or death from any cause.
Time Frame
3 years
Title
perioperative complications
Description
perioperative complications
Time Frame
the time from the start of randomization to 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
Male or female patients between the ages of 18-75;
Patients diagnosed as gastric adenocarcinoma by histology or cytology;
Stage: Locally advanced stage (T3-4aN1-3M0);
Have not received other immunotherapy drugs or chemotherapy drugs in the past;
ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
Has sufficient organ and bone marrow function
Exclusion Criteria:
Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
A distant metastasis occurs;
Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
Patients with any severe and/or uncontrollable disease;
Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
Received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping;
Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
Participated in other anti-tumor drug clinical trials within four weeks;
According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
Female patients who are pregnant or breastfeeding;
Known hypersensitivity to any study drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CAI Zhenghao
Phone
17316533505
Email
c3z2h1@alumni.sjtu.edu.cn
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CAI Zhenghao
Phone
17316533505
Email
c3z2h1@alumni.sjtu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer
We'll reach out to this number within 24 hrs