NCT06507371Active, not recruitingPhase 3
Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
Node-sparing Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer : An Randomized, Prospective, Multicenter, Open-label, Phase III Clinical Trial (mRCAT-III)
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
This is a randomized, prospective, multicenter, open-label, Phase III clinical trial to evaluate node-sparing modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) compared with standard short-course radiation combined with CAPOX for patients with MSS middle and low rectal cancer. A total of 170 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The EFS rate, ORR, organ preservation rate, long-term prognosis, and adverse effects will also be analyzed.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 3 Jul 2024
- Start date
- 29 Jul 2024
- Primary completion date
- 4 May 2026
- Lead sponsor
- Sir Run Run Shaw Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06507371
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 170
- From 29 Jul 2024 to the primary completion date, 4 May 2026
- 1 site in 1 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
- Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
- Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
- Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.
Other illness
- Patients with a previous history of malignant tumors besides rectal cancer.
- Patients with obstruction, perforation, or bleeding that require emergency surgery.
- Allergic to any component of the therapy.
- Patients with congenital or acquired immune deficiency (such as HIV infection).
- Other conditions that investigators consider not suitable for this study.
Lab values
- Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities.
Other
- Patients with distant metastases before enrollment.
- Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.
- Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.
Who the study is looking for
- Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
- Male or Female aged 18-75.
- Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT3-4bN0/+M0, and the lymph nodes are limited to the mesorectum.
- Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
- Eastern Cooperative Oncology Group (ECOG) score 0-1.
- No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation).
- Laboratory tests indicating no contraindications to radiotherapy, chemotherapy and immunotherapy.
- Informed consent form signed.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shao hospital Coordinator of this site? Confirm its status | Hanzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.