Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer
1 other identifier
interventional
130
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2026
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2026
CompletedFirst Posted
Study publicly available on registry
March 13, 2026
CompletedStudy Start
First participant enrolled
August 10, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2027
Study Completion
Last participant's last visit for all outcomes
September 1, 2027
March 13, 2026
March 1, 2026
1 year
March 6, 2026
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Response (CR) Rate
Including pCR and CCR.
t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.
Secondary Outcomes (7)
Organ Preservation Rate
1 year.
Surgical Complications
Within 30 days post-surgery
the Quality of Life
Baseline, before surgery, and up to 12 months after surgery
Grade ≥3 Adverse Event Rate
From start of treatment to 30 days after last dose, up to approximately 6 months
3y-DFS
From enrollment to 36 month
- +2 more secondary outcomes
Study Arms (2)
Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab
EXPERIMENTALModified Short-course radiotherapy (GTV-P: 30 Gy/5f , CTV-P: 22.5 Gy/5 f),followed by Oxaliplatin ,Capecitabine and Tislelizumab q3w \*4 cycles.Efficacy and surgery were assessed after the end of treatment.
Long-course radiotherapy Combined with Capecitabine and Tislelizumab
ACTIVE COMPARATORLong-course radiotherapy (50.4 Gy/25 f) with concurrent Capecitabine (on radiation days) and Tislelizumab (q3w, 3cycles).Efficacy and surgery were assessed after the end of treatment.
Interventions
Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f
130 mg/m²,d1, q3w ,4 cycles
1000 mg/m, d1-14,bid,q3w, 4 cycles
200mg,d1,q3w,4 cycles
Eligibility Criteria
You may qualify if:
- 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 immunotherapy.
- Ability to comply with the study protocol during the study period.
- Signed written informed consent.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The Second Hospital of Longyan
Longyan, Fujian, 364000, China
Jinjiang Municipal Hospital
Quanzhou, Fujian, 362200, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiunluan Li, MD
Fujian Cancer Hospital
- PRINCIPAL INVESTIGATOR
Chunkang Yang, MD
Fujian Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2026
First Posted
March 13, 2026
Study Start (Estimated)
August 10, 2026
Primary Completion (Estimated)
August 10, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
March 13, 2026
Record last verified: 2026-03