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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
      • Hangzhou, China
        • The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
        • Contact:
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology/cytology and negative for HER-2 by IHC/FISH
  2. The presence of gastric cancer peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20
  3. Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  4. ECOG (Eastern Cooperative Oncology Group) : 0~1
  5. There is at least one measurable lesion according to the RECISTv1.1
  6. Normal hemodynamic indices before the recruitment
  7. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
  8. 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.
  9. Signed the Informed Consent Form

Exclusion Criteria:

  1. 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)
  2. 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
  3. Ever operation on the stomach
  4. Serious diseases that are difficult to control
  5. Allergy to the drugs in this protocol
  6. There are many factors that affect the absorption of oral drugs, including inability to swallow, chronic diarrhea, intestinal obstruction and so on.
  7. The peripheral neuropathy was more than 1 grade
  8. 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.
  9. 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).
  10. 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.
  11. The live attenuated vaccine shall be inoculated within 4 weeks before the first administration or during the study period
  12. 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
  13. A history of psychoactive substance abuse or abuse is known
  14. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: HIPEC, anti-PD-1 antibody Camrelizumab (SHR-1210), Chemotherapy and Surgery
  1. surgical exploration, if PCI<20, then we perform this study.
  2. HIPEC: Taxol (Paclitaxel Injection) 75 mg/m2, d1, d3 within 72 hours after surgical exploration; oral chemotherapy:S-1: 80mg/m2, twice daily for d1-d14, and then suspend for one week; Intravenous drip anti-PD-1 antibody Camrelizumab (SHR-1210) 200mg fixed dose every 3 weeks.
  3. Chemotherapy and PD-1 treatment (4 cycles) : Taxol 150mg/m2,d1; S-1: 80-120mg/m2, twice daily for two weeks, and then suspend for one week; Camrelizumab (SHR-1210) 200mg fixed dose every 3 weeks.
  4. Surgery: Secondary surgical exploration: if PCI less than 20, then assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases ). For inoperable patients, continue to use this program for treatment.
  5. After the surgery, HIPEC for two cycles, anti-PD-1 antibody Camrelizumab (SHR-1210) for 4 cycles, and PS chemotherapy for 4 cycles.
Drug: HIPEC, anti-PD-1 antibody Camrelizumab (SHR-1210), Chemotherapy and Surgery
  1. HIPEC: Taxol (Paclitaxel Injection) 75 mg/m2, d1, d3 within 72 hours after surgical exploration; oral chemotherapy:S-1: 80mg/m2, twice daily for d1-d14, and then suspend for one week; Intravenous drip anti-PD-1 antibody Camrelizumab (SHR-1210) 200mg fixed dose every 3 weeks.
  2. Chemotherapy and PD-1 treatment (4 cycles) : Taxol 150mg/m2,d1; S-1: 80-120mg/m2, twice daily for two weeks, and then suspend for one week; Camrelizumab (SHR-1210) 200mg fixed dose every 3 weeks.
  3. Surgery: Secondary surgical exploration: if PCI less than 20, then assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases ). For inoperable patients, continue to use this program for treatment.
  4. After the surgery, HIPEC for two cycles, anti-PD-1 antibody Camrelizumab (SHR-1210) for 4 cycles, and PS chemotherapy for 4 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
R0 resection
Time Frame: 3 months
the rate of R0 resection
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 3 years
Number and degree of Adverse Events
3 years
Overall survival time
Time Frame: 3 years
the overall survival time
3 years
Disease-Free Survival
Time Frame: 3 years
Disease-Free Survival of participants with with advanced gastric cancer with peritoneal metastasis followed by surgery
3 years
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Cancer Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

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