Clinical trial · Interventional
Modified SCRT Followed by Tislelizumab Plus CAPOX for Locally Advanced Rectal Cancer
A Phase II Multicenter Clinical Trial of Modified Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
NCT06333769CI-TRIAL-00093710completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mid-low Rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Short-course Radiotherapy | Radiation | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab
- description
- Modified SCRT (GTV 30Gy/5f, CTV 22.5Gy/5f), followed by Tislelizumab and CAPOX q3w \*2 cycles. Efficacy and surgery were assessed 2-4 weeks after the end of treatment.
- interventionNames
- Radiation: Short-course Radiotherapy
- Drug: Tislelizumab
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Complete response (CR) rate
- timeFrame
- From enrollment to 3 month and during follow-up
- description
- Including pCR and CCR.
Secondary outcomes (4)
- measure
- Organ preservation rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.