Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC (NCT07448077) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC
128 participantsStarted 2026-03-01
Plain-language summary
Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.