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ClinicalTrials.gov ID

NCT07469306

Lead Sponsor

Fujian Cancer HospitalOTHER_GOV

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

130Estimated

Last Update Posted

Mar 13, 2026Actual

Start Date

Aug 10, 2026Estimated

Primary Completion Date

Aug 10, 2027Estimated

Completion Date

Sep 1, 2027Estimated

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

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.

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.

• Locally Advanced Rectal Cancer

• Modified Short-course radiotherapy
• Long-course radiotherapy
• Oxaliplatin
• Capecitabine
• Tislelizumab

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Fujian Cancer HospitalOTHER_GOV

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