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Recruiting NCT07448077

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

Phase II Interventional Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR 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: Experimental: short-course radiotherapy and immunotherapy, Chemoradiotherapy.
Who it may be relevant to
Registry conditions: Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer. Basic parameters: from 18 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 →

Unsure about the terms? Read our patient guide →

Official title

Short-Course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial

Overview

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

Interventions

  • Drug Experimental: short-course radiotherapy and immunotherapy
    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
  • Drug Chemoradiotherapy
    Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy

Primary outcome measures

  • complete response Rate (pCR+cCR ) [Time frame: up to 2 year]
Secondary outcome measures (5)
  • Major pathologic response rate [Time frame: up to 2 year]
  • R0 resection rate [Time frame: The R0 resection rate will be evaluated after surgery, an average of 4 weeks]
  • 3-year event-free survival (EFS) rate [Time frame: up to 3 years]
  • 3-year overall survival (OS) [Time frame: up to 3 years]
  • Adverse Event [Time frame: up to 2 year]

Eligibility criteria

Inclusion criteria

  • 1.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 .

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.

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 · 1 center
  • Hebei Medical University Fourth Hospital — Shijiazhuang

Identifiers

NCT: NCT07448077 · CSPC-ESX-CRC-K01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗