LDRT Sequential NIPS Immunochemotherapy for Peritoneal Metastasis of Gastric and Colorectal Cancer (TRIUNITE06)

April 22, 2026 updated by: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

A Prospective, Single-center, Single-arm Clinical Study on the Safety and Efficacy of LDRT Sequential NIPS Immunochemotherapy for Peritoneal Metastasis of Gastric and Colorectal Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-center, Ib-phase clinical study. At least 9 eligible participants will be recruited in this study. After all participants are enrolled, they will receive LDRT treatment once on the first day of each of the first 3 cycles, with LDRT treatment doses of 1.5Gy/3F, 3Gy/3F, and 4.5Gy/3F respectively. Then, NIPS Immunochemotherapy will be administered in sequence. The primary endpoint is safety and tolerability.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400042
        • Army Medical Center
      • Chongqing, Chongqing Municipality, China, 400042
        • Daping Hospital, Army Medical University
        • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between18 and 75 years old.
  2. 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).
  3. An Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, patients must have measurable disease within the irradiated area.
  5. Expected survival period≥3 months
  6. Adequate cardiac function (Left Ventricular Ejection Fractions > 50%), hepatic function (total serum bilirubin ≤ 1.5 ×upper limit of normal, alanine aminotransferase or aspartate aminotransferase ≤ 2.5 × upper limit of normal), renal function (serum creatinine ≤ 1.5 × ULN or glomerular filtration rate > 60 ml/min, based on Cockcroft-Gault), and hematopoietic function (white blood cells ≥ 4.0 × 109 cells per L, neutrophils ≥ 1.5 × 109 cells per L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 109 cells per L).
  7. Sign the informed consent and have good compliance.

Exclusion Criteria:

  1. Presence of distant metastasis other than peritoneal metastasis (ovarian metastasis is allowed);
  2. 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;
  3. Upper gastrointestinal obstruction or physiological dysfunction, or suffering from malabsorption syndrome, which may affect the absorption of oral drugs;
  4. 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;
  5. History of immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation or allogeneic bone marrow transplantation);
  6. Moderate or severe renal impairment (creatinine clearance ≤ 50 ml/min);
  7. Allergy to paclitaxel, oxaliplatin, monoclonal antibodies or any component of the study drug;
  8. Pregnant or lactating women;
  9. Presence of clinically detectable second primary malignancy, or a history of other malignancies within 5 years, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and superficial bladder tumors (non-invasive tumors, or carcinoma in situ, or T1);
  10. Uncontrolled epilepsy, central nervous system disease or mental disorder, as judged by the investigator to be clinically significant enough to prevent signing the informed consent or affect the patient's compliance with drug treatment.

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: LDRT followed by NIPS treatment（CAPEOX/SOX+ICB 4-6 cycles）
For patients with peritoneal metastasis of gastric and colorectal cancer:During the first 3 treatment cycles, LDRT was administered on the first day of each cycle, followed by sequential NIPS treatment(CAPEOX/SOX+ICB 4-6 cycles).
Radiation: LDRT
1.5Gy in 3 fractions, 3.0 Gy in 3 fractions, 4.5Gy in 3 fractions respectively in three Cohorts from Day1
Drug: SOX or CAPOX regimen

For colorectal cancer：Oxaliplatin: 100mg/m2 IV and 30mg/m2 IP Q3W on day 1 of each cycle. Capecitabine: 1000mg/m2 Q3W on day 1-14 of each cycle.

For gastric cancer：Oxaliplatin: 100mg/m2 IV and 30mg/m2 IP Q3W on day 1 of each cycle. Tegafur: 80mg/m2 Q3W on day 1-14 of each cycle

Drug: Tislelizumab
Tislelizumab:100 mg IV and 100 mg IP Q3W on day 1 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events
Time Frame: 2 years
Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and tolerability of LDRT sequential NIPS with CAPEOX/SOX and Tislelizumab
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 2 years
Investigator assessed ORR using RECIST v1.1 including the all tumor
2 years
Progression-free survival (PFS)
Time Frame: 2 years
Defined as the time from initiation of treatment to tumor progression or death from any cause.
2 years
Overall survival (OS)
Time Frame: 3 years
Defined as the time from initiation of treatment to death from any cause.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Investigators

  • Study Director: Chuan Chen, MD PhD, Daping Hospital, Army Medical University

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP2025458

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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