LDRT Sequential NIPS Immunochemotherapy for Peritoneal Metastasis of Gastric and Colorectal Cancer

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

There have been initial explorations on the treatment of peritoneal metastasis of gastric and colorectal cancer both at home and abroad. However, the comprehensive treatment plan of "LDRT + NIPEC + immunotherapy + systemic therapy" has not been reported either domestically or internationally. This study will explore the safety and efficacy of total abdominal low-dose radiotherapy followed by NIPEC and PD-1 treatment for peritoneal metastasis of gastric and colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.

Eligibility criteria

Qualifiers

Age between18 and 75 years old.

Histologically confirmed gastric cancer/colon cancer, and diagnosed as peritoneal metastasis of tumor through laparoscopy/puncture (patients must have metastatic tumors located within the peritoneal cavity).

An Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, patients must have measurable disease within the irradiated area.

Disqualifiers

Presence of distant metastasis other than peritoneal metastasis (ovarian metastasis is allowed);

Presence of uncontrolled clinical symptoms or diseases of the heart, including but not limited to: (1) NYHA class II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain uncontrolled after clinical intervention;

Upper gastrointestinal obstruction or physiological dysfunction, or suffering from malabsorption syndrome, which may affect the absorption of oral drugs;

Severe infection (CTCAE > grade 2) or other concomitant diseases within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging shows active pulmonary inflammation, or symptoms and signs of infection within 14 days before the first use of the study drug, or requiring oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics; active pulmonary tuberculosis infection is found through medical history or CT examination, or there is a history of active pulmonary tuberculosis within 1 year before enrollment, or there is a history of active pulmonary tuberculosis more than 1 year ago but without regular treatment;

Trial design

Treatments tested in this trial

  • LDRT
  • SOX or CAPOX regimen
  • Tislelizumab

Treatment groups

9 Participants
are divided into 1 treatment group