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Modified SCRT Followed by Tislelizumab Plus CAPOX for Locally Advanced Rectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT06333769•Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer

Detailed Description

In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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).
+1 more criteria

Locations (3)

Fujian Cancer Hospital

Fuzhou, Fujian, China

The Second Hospital of Longyan

Longyan, Fujian, China

Jinjiang Municipal Hospital

Quanzhou, Fujian, China

Key Dates

Start Date

July 12, 2024

Primary Completion Date

August 10, 2025

Completion Date

August 14, 2025

Last Updated

August 15, 2025

Enrollment

ACTUAL participants

Conditions

Mid-low Rectal Cancer

Interventions

Short-course Radiotherapy

RADIATION

Tislelizumab

DRUG

Capecitabine

DRUG

Oxaliplatin

DRUG