Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Modified Short-course radiotherapy, Long-course radiotherapy, Oxaliplatin, Capecitabine.
- Who it may be relevant to
- Registry conditions: Locally Advanced Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
In the exploration of treatments for locally advanced rectal cancer (LARC), the novel model combining short-course radiotherapy with CAPOX chemotherapy and PD-1 inhibitor (tislelizumab) is demonstrating promising potential. By comparing the efficacy and safety of modified short-course radiotherapy versus traditional long-course radiotherapy within this combination regimen, this study aims to identify the optimal radiotherapy strategy to maximize tumor regression and improve the complete response rate, thereby offering a more promising treatment option for rectal cancer patients seeking organ preservation.
Interventions
- Radiation Modified Short-course radiotherapy
Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx. - Radiation Long-course radiotherapy
Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f - Drug Oxaliplatin
130 mg/m²,d1, q3w ,4 cycles - Drug Capecitabine
1000 mg/m, d1-14,bid,q3w, 4 cycles - Drug Tislelizumab
200mg,d1,q3w,4 cycles - Drug Capecitabine
825 mg/m² ,BID ,on radiation days - Drug Tislelizumab
200mg,d1,q3w,3 cycles
Primary outcome measures
- Complete Response (CR) Rate [Time frame: t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.]
Secondary outcome measures (7)
- Organ Preservation Rate [Time frame: 1 year.]
- Surgical Complications [Time frame: Within 30 days post-surgery]
- the Quality of Life [Time frame: Baseline, before surgery, and up to 12 months after surgery]
- Grade ≥3 Adverse Event Rate [Time frame: From start of treatment to 30 days after last dose, up to approximately 6 months]
- 3y-DFS [Time frame: From enrollment to 36 month]
- 3y-LRFS [Time frame: From enrollment to 36 month]
- 3y-OS [Time frame: From enrollment to 36 month]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Fujian Cancer Hospital — Fuzhou
- The Second Hospital of Longyan — Longyan
- Jinjiang Municipal Hospital — Quanzhou
Identifiers
NCT: NCT07469306 · CATIMOR-2