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

NCT07453875 | Not Yet Recruiting Phase 1

• 1 other identifier: DP2025458
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Peritoneal Metastasis of Gastric and Colorectal Cancer; LDRT

Keywords

Gastric and colorectal cancer; LDRT; NIPS; Immunochemotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  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 Outcomes (3)

• Objective Response Rate (ORR)

  2 years

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  3 years

Study Arms (1)

LDRT followed by NIPS treatment（CAPEOX/SOX+ICB 4-6 cycles）

EXPERIMENTAL

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; Drug: SOX or CAPOX regimen; Drug: Tislelizumab

Interventions

LDRT RADIATION

1.5Gy in 3 fractions, 3.0 Gy in 3 fractions, 4.5Gy in 3 fractions respectively in three Cohorts from Day1

LDRT followed by NIPS treatment（CAPEOX/SOX+ICB 4-6 cycles）

SOX or CAPOX regimen DRUG

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

LDRT followed by NIPS treatment（CAPEOX/SOX+ICB 4-6 cycles）

Tislelizumab DRUG

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

LDRT followed by NIPS treatment（CAPEOX/SOX+ICB 4-6 cycles）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Expected survival period≥3 months
• 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).
• Sign the informed consent and have good compliance.

You may not qualify if:

• 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;
• 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);
• Moderate or severe renal impairment (creatinine clearance ≤ 50 ml/min);
• Allergy to paclitaxel, oxaliplatin, monoclonal antibodies or any component of the study drug;
• Pregnant or lactating women;
• 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);
• 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.

Sponsors & Collaborators

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

Study Sites (2)

Army Medical Center

Chongqing, Chongqing Municipality, 400042, China

Location

Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

XELOX; tislelizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Chuan Chen, MD PhD

  Daping Hospital, Army Medical University

  STUDY DIRECTOR

Central Study Contacts

Chuan Chen, MD PhD

CONTACT

13883089634; sinkriver@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)