- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04889768
HIPEC Combined With Camrelizumab, Paclitaxel and S-1 for Conversion Therapy in Patients With Advanced Gastric Cancer With Peritoneal Metastasis
May 12, 2021 updated by: Zhejiang Cancer Hospital
There is no currently available treatment for peritoneal metastasis of gastric cancer.
Hyperthermic intraperitoneal chemotherapy (HIPEC) can not only maintain the high concentration of drugs in the abdominal cavity, but also improve the anti-tumor efficacy of chemotherapy drugs through the thermo-thermal effect.
In recent years, immunotherapy has made great progress in the treatment of gastric cancer.
We want to explore the hyperthermic intraperitoneal chemotherapy (HIPEC) combined with Camrelizumab (SHR-1210) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, anti-PD-1 antibody Camrelizumab (SHR-1210), intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis, so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.
Study Type
Interventional
Enrollment (Anticipated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hangzhou, China
- The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
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Contact:
- Yian Du
- Phone Number: 86-571-88128031
- Email: ypfzmu@163.com
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Contact:
- Pengfei Yu
- Phone Number: 86-571-88128031
- Email: ypfzmu@163.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology/cytology and negative for HER-2 by IHC/FISH
- The presence of gastric cancer peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20
- Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
- ECOG (Eastern Cooperative Oncology Group) : 0~1
- There is at least one measurable lesion according to the RECISTv1.1
- Normal hemodynamic indices before the recruitment
- Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
- Fertile female subjects must undergo a serum-negative pregnancy test within 72 hours before starting the study drug and must agree to use a medically approved effective contraceptive during the study period and within 180 days of the last dose of the study drug; Male subjects whose partners are women of child-bearing age should undergo surgical sterilization or agree to use effective methods of contraception during the study period and within 180 days of the last study administration.
- Signed the Informed Consent Form
Exclusion Criteria:
- Immunosuppressive drugs were used within 30 days before the first use of carrlizumab, excluding nasal spray and inhaled corticosteroids or systemic steroids in physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids in physiological dose of the same drug)
- There is any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and those who do not need any intervention after adulthood can be included Asthma requiring medical intervention with bronchodilator was not included.) Distal metastasis to lung, liver, or paraaortic lymph node metastasis
- Ever operation on the stomach
- Serious diseases that are difficult to control
- Allergy to the drugs in this protocol
- There are many factors that affect the absorption of oral drugs, including inability to swallow, chronic diarrhea, intestinal obstruction and so on.
- The peripheral neuropathy was more than 1 grade
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of the analysis method) or co infection with hepatitis B and C.
- Active infection (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs) or fever of unknown origin >38.5℃ 1 weeks ago (except for tumor related fever determined by researchers).
- Abnormal coagulation (INR > 1.5 or APTT > 1.5 × ULN), bleeding tendency or undergoing thrombolysis or anticoagulation. Long term anticoagulation with warfarin or heparin or long-term antiplatelet therapy is required.
- The live attenuated vaccine shall be inoculated within 4 weeks before the first administration or during the study period
- Any other malignant tumor has been diagnosed within 3 years before the study, except for basal cell or squamous cell skin cancer or cervical carcinoma in situ which has been fully treated
- A history of psychoactive substance abuse or abuse is known
- The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: HIPEC, anti-PD-1 antibody Camrelizumab (SHR-1210), Chemotherapy and Surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R0 resection
Time Frame: 3 months
|
the rate of R0 resection
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 3 years
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Number and degree of Adverse Events
|
3 years
|
Overall survival time
Time Frame: 3 years
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the overall survival time
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3 years
|
Disease-Free Survival
Time Frame: 3 years
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Disease-Free Survival of participants with with advanced gastric cancer with peritoneal metastasis followed by surgery
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3 years
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ORR
Time Frame: 3 years
|
Objective Response Rate
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 31, 2021
Primary Completion (Anticipated)
July 31, 2023
Study Completion (Anticipated)
July 31, 2025
Study Registration Dates
First Submitted
May 12, 2021
First Submitted That Met QC Criteria
May 12, 2021
First Posted (Actual)
May 17, 2021
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 12, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2021-63
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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