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Peritoneal Metastasis of Gastric and Colorectal CancerPhase 1TRIUNITE06NCT07453875

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

A Phase 1 study testing LDRT, SOX or CAPOX regimen and Tislelizumab in people with Peritoneal Metastasis of Gastric and Colorectal Cancer and LDRT, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
LDRT, SOX or CAPOX regimen and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
2 sitesChina
Study dates
May 2026to 30 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chuan Chen, MD PhD contact

13883089634

sinkriver@126.com

China2 sites

  • Army Medical Center

    Chongqing, Chongqing Municipality, 400042

  • Daping Hospital, Army Medical University

    Chongqing, Chongqing Municipality, 400042

    Chuan Chen, 13883089634, sinkriver@126.com

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
LDRT, SOX or CAPOX regimen, Tislelizumab
Keywords
Gastric and colorectal cancer, LDRT, NIPS, Immunochemotherapy
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LDRTRadiation

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

  • SOX or CAPOX regimenDrug

    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

  • TislelizumabDrug

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

Study groups in NCT07453875
Study groupRoleWhat they receive
LDRT followed by NIPS treatment（CAPEOX/SOX+ICB 4-6 cycles）ExperimentalFor 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).
Receives: Radiation: LDRT; Drug: SOX or CAPOX regimen; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    Investigator assessed ORR using RECIST v1.1 including the all tumor

    Measured: 2 years

  2. Progression-free survival (PFS)

    Defined as the time from initiation of treatment to tumor progression or death from any cause.

    Measured: 2 years

  3. Overall survival (OS)

    Defined as the time from initiation of treatment to death from any cause.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study startMay 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07453875
Sponsor's protocol ID
DP2025458
Acronym
TRIUNITE06
Status last verified
Apr 2026
First submitted
2 Mar 2026
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LDRT, SOX or CAPOX regimen and Tislelizumab in people with Peritoneal Metastasis of Gastric and Colorectal Cancer and LDRT, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chuan Chen, MD PhD (13883089634, sinkriver@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07453875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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