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NCT05648487Not yet recruitingPhase 2

HIPEC Combined With Sintilimab for Gastric Cancer With Peritoneal Metastasis

A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Sintilimab in Gastric Cancer With Peritoneal Metastasis

Source: ClinicalTrials.gov · Last updated 16 Dec 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

To evaluate the Safety and Efficacy of HIPEC Combined With Sintilimab for Gastric Cancer Patients with Peritoneal Metastasis.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
46 (estimated)
First submitted
5 Dec 2022
Start date
1 Jan 2023
Primary completion date
31 Mar 2025
Lead sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
NCT number
NCT05648487

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 46
  • From 1 Jan 2023 to the primary completion date, 31 Mar 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous systemic therapy for gastric cancer;
  • Immunosuppressive drugs(eg.Corticosteroids) were used within 14 days before treatment, eg.corticosteroids,

Other illness

  • Recurrent gastric cancer after surgery;
  • 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.)
  • Allergy to the drugs in this protocol;
  • Patients with other diseases not suitable for inclusion, such as immune deficiency, active tuberculosis, hepatitis B (non-active hepatitis B surface antigen (HBsAg) carriers, hepatitis B virus titer \<500IU/ml after treatment and with normal liver function can be included), hepatitis C virus positive;
  • A history of idiopathic pulmonary fibrosis, tissue pneumonia, drug pneumonia, idiopathic pneumonia, or r active pneumonia;

Other

  • Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.);
  • Cardiopulmonary dysfunction;
  • Other patients who were considered unsuitable for inclusion by the researchers;

Who the study is looking for

  • Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
  • Age 18-75 years, Male or Non pregnant female
  • ECOG (Eastern Cooperative Oncology Group) : 0\~1;
  • Negative for HER-2 by IHC/FISH;
  • Peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20;
  • Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
  • Normal Bone marrow, liver and kidney function indices before the recruitment:
  • Expected survival≥ 12 week
  • Signed the Informed Consent Form, and blood and tissue samples can be obtained;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.