NCT07469306 Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
| NCT ID | NCT07469306 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fujian Cancer Hospital |
| Condition | Locally Advanced Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-08-15 |
| Primary Completion | 2027-08-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2026-08-15 with a primary completion date of 2027-08-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.
Eligibility Criteria
Inclusion Criteria: * Age 18-75 years, any gender. * Pathologically confirmed rectal adenocarcinoma. * Baseline MR stage T3-4/N+. * Distance from anal verge ≤12cm. * No distant metastasis. * Karnofsky Performance Status ≥70. * Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy. * Microsatellite/mismatch repair status MSS/pMMR. * No prior chemotherapy or any other anti-tumor treatment before inclusion. * No prior immunotherapy. * Ability to comply with the study protocol during the study period. * Signed written informed consent. Exclusion Criteria: * Pregnant or lactating women. * Pathological diagnosis of signet ring cell carcinoma. * History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ. * Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication. * Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months. * Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users. * Patients with autoimmune diseases. * Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities. * Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L. * Known deficiency of dihydropyrimidine dehydrogenase (DPD). * Allergy to any investigational drug components.
Contact & Investigator
Jiunluan Li, MD
PRINCIPAL INVESTIGATOR
Fujian Cancer Hospital
Frequently Asked Questions
Who can join the NCT07469306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Locally Advanced Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07469306 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07469306 currently recruiting?
Yes, NCT07469306 is actively recruiting participants. Contact the research team at lijinluan@fjmu.edu.cn for enrollment information.
Where is the NCT07469306 trial being conducted?
This trial is being conducted at Fuzhou, China, Longyan, China, Quanzhou, China.
Who is sponsoring the NCT07469306 clinical trial?
NCT07469306 is sponsored by Fujian Cancer Hospital. The principal investigator is Jiunluan Li, MD at Fujian Cancer Hospital. The trial plans to enroll 130 participants.
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