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Clinical Trials in China / NCT07469306
Starting soon Phase 2

Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer

NCT07469306 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Cancer Hospital
Phase
Phase 2
Started
2026-08-10
Last updated
2026-03-13

Condition(s) studied

Locally Advanced Rectal Cancer

Investigational drug(s) / intervention(s)

Modified Short-course radiotherapyLong-course radiotherapyOxaliplatinCapecitabineTislelizumabCapecitabineTislelizumab

Modified Short-course radiotherapy: Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.

Long-course radiotherapy: Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f

Oxaliplatin: 130 mg/m²,d1, q3w ,4 cycles

Capecitabine: 1000 mg/m, d1-14,bid,q3w, 4 cycles

Tislelizumab: 200mg,d1,q3w,4 cycles

Capecitabine: 825 mg/m² ,BID ,on radiation days

Tislelizumab: 200mg,d1,q3w,3 cycles

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Fujian Cancer Hospital Fuzhou Fujian
The Second Hospital of Longyan Longyan Fujian
Jinjiang Municipal Hospital Quanzhou Fujian

More Fujian Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07469306 on ClinicalTrials.gov ↗ ← All trials in China