NCT07448077RecruitingPhase 2
Short-Course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
Hebei Medical University Fourth Hospital1 site in 1 country128 target enrollmentStarted: March 1, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- complete response Rate (pCR+cCR )
Study Overview
Brief Summary
Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1.age >=18 years old, female and male. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •3.Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR .
- •4.Staged as T3-4 NanyM0 or T1-2N+ M0 according to the AJCC 8th edition. 5.Rectal cancer: <10 cm from the anal verge. 6.Adequate organ function:
- •Hematology : i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L. ii. Platelet count ≥ 100 × 10⁹/L . iii. Hemoglobin ≥ 90 g/L.
- •Hepatic: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (Upper Limit of Normal). ii. AST and ALT ≤ 2.5 × ULN. iii. Creatinine ≤ 1.5 × ULN ; Renal: Calculated Creatinine Clearance (CrCl) ≥ 60 mL/min (calculated using the Cockcroft-Gault formula)
- •Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
- •7. Men and women of childbearing potential must agree to use effective contraceptive measures during the study and for 6 months after the last treatment.
- •8. Willing and able to voluntarily provide written informed consent and comply with all scheduled treatments and follow-up assessments.
Exclusion Criteria
- •Pathological diagnosis of other special types, including but not limited to neuroendocrine carcinoma or squamous cell carcinoma.
- •Has previously received radiotherapy, targeted agents, or immune checkpoint inhibitors for the treatment of rectal cancer.
- •Active autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, necessitating ongoing immunosuppressive treatment.
- •Has active infection, including but not limited to HIV, or positive HBV/HCV viral load requiring antiviral therapy for control and stabilization.
- •Significant cardiovascular disease, such as myocardial infarction within 6 months prior to enrollment, unstable angina pectoris, or hypertension that remains uncontrolled above 160/100 mmHg despite optimal therapy.
- •History of other malignant tumors, excluding non-melanoma skin cancer and cervical carcinoma in situ that have been curatively treated and disease-free for ≥ 5 years.
- •Uncontrolled diabetes (HbA1c > 8%) or thyroid dysfunction requiring medication for abnormal TSH.
- •Severe chronic intestinal conditions，including but not limited to Crohn's disease or active ulcerative colitis.
- •The investigators believe that patients were inappropriate for participation.
Arms & Interventions
short-course radiotherapy and immunotherapy
Experimental
patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart
Intervention: Experimental: short-course radiotherapy and immunotherapy (Drug)
chemoradiotherapy
Active Comparator
Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy
Intervention: Chemoradiotherapy (Drug)
Outcomes
Primary Outcomes
complete response Rate (pCR+cCR )
Time Frame: up to 2 year
Clinical complete response or pathological complete response (cCR or pCR)
Secondary Outcomes
- Major pathologic response rate(up to 2 year)
- R0 resection rate(The R0 resection rate will be evaluated after surgery, an average of 4 weeks)
- 3-year event-free survival (EFS) rate(up to 3 years)
- 3-year overall survival (OS)(up to 3 years)
- Adverse Event(up to 2 year)
Investigators
Fengpeng WU, MD
Hebei Medical University Fourth Hospital
Hebei Medical University Fourth Hospital
Study Sites (1)
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