Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC

NCT07448077 | Not Yet Recruiting Phase 2

• 1 other identifier: CSPC-ESX-CRC-K01
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer

Conditions

Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• complete response Rate (pCR+cCR )

  Clinical complete response or pathological complete response (cCR or pCR)

  up to 2 year

Secondary Outcomes (5)

• 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

Study Arms (2)

short-course radiotherapy and immunotherapy

EXPERIMENTAL

patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart

Drug: Experimental: short-course radiotherapy and immunotherapy

chemoradiotherapy

ACTIVE COMPARATOR

Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy

Drug: Chemoradiotherapy

Interventions

Experimental: short-course radiotherapy and immunotherapy DRUG

patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart Enlonstobart 200mg IV every 3 weeks; Oxaliplatin 130mg/m2 IV Q3W d1 Capecitabine 1000mg/m2 bid d1-14 q3w

short-course radiotherapy and immunotherapy

Chemoradiotherapy DRUG

Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy

chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>=18 years old, female and male. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3.Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR .
• 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.
• \. Men and women of childbearing potential must agree to use effective contraceptive measures during the study and for 6 months after the last treatment.
• \. Willing and able to voluntarily provide written informed consent and comply with all scheduled treatments and follow-up assessments.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

MeSH Terms

Interventions

Immunotherapy; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Combined Modality Therapy; Drug Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hebei Medical University Fourth Hospital

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 4, 2026
• Study Start: March 1, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share