Short-course Radiotherapy Plus Enlonstobart in pMMR Locally Advanced Rectal Cancer
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
Run by Hebei Medical University Fourth Hospital · NCT07448077 · Data updated 2026-11-12
This study tests a short course of radiotherapy combined with enlonstobart in adults with pMMR locally advanced rectal cancer to see if this approach is safe and effective.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | March 1, 2026 |
| Study ends | June 30, 2030 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT07448077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with pMMR locally advanced rectal cancer, adequate organ function, ECOG 0–1, specific AJCC 8th edition staging (T3-4 Nany M0 or T1-2N+ M0) and tumor within 10 cm of the anal verge.
✕Probably not a fit
Patients with inadequate organ function, ECOG >1, non-pMMR status, distant metastases, or histology not meeting the eligibility criteria may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 interventional trial evaluates the safety and activity of a short-course radiotherapy regimen given as part of total neoadjuvant therapy with the investigational agent enlonstobart for patients with pMMR locally advanced rectal cancer. Eligible participants are adults with suitable performance status and specific tumor stages, including rectal cancer within 10 cm of the anal verge, and adequate organ function. The study uses a defined radiotherapy schedule in combination with immunotherapy and chemoradiotherapy to assess tumor response and treatment tolerability in the neoadjuvant setting. Primary outcomes typically include safety and preliminary efficacy measures, with secondary endpoints related to pathologic response and surgical feasibility.
Why it matters
Potential benefit: If successful, patients may experience improved tumor response and potentially better surgical outcomes with a shorter overall treatment timeline.
How similar studies have gone: Prior similar approaches combining radiotherapy with immunotherapy in colorectal cancer have shown signals of activity but remain investigational with variable outcomes, making this study exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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:
1. Hematology : i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L. ii. Platelet count ≥ 100 × 10⁹/L . iii. Hemoglobin ≥ 90 g/L.
2. 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)
3. 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:
1. Pathological diagnosis of other special types, including but not limited to neuroendocrine carcinoma or squamous cell carcinoma.
2. Has previously received radiotherapy, targeted agents, or immune checkpoint inhibitors for the treatment of rectal cancer.
3. Active autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, necessitating ongoing immunosuppressive treatment.
4. Has active infection, including but not limited to HIV, or positive HBV/HCV viral load requiring antiviral therapy for control and stabilization.
5. 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.
6. 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.
7. Uncontrolled diabetes (HbA1c \> 8%) or thyroid dysfunction requiring medication for abnormal TSH.
8. Severe chronic intestinal conditions，including but not limited to Crohn's disease or active ulcerative colitis.
9. The investigators believe that patients were inappropriate for participation.
Where it's running
-
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China Recruiting
Study contacts
- Study coordinator: Linlin Xiao, Dr
- Email: drxiaolinlin@163.com
- Phone: 18533167355
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.