Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immuno… (NCT07581626) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer
China60 participantsStarted 2026-05-01
Plain-language summary
Standard treatment for patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) locally advanced rectal cancer (LARC) consists primarily of neoadjuvant chemoradiotherapy followed by radical surgery. Several studies (including the UNION, STELLAR, TORCH, and SPRING-01 trials, etc) have demonstrated that the neoadjuvant strategy of short-course radiotherapy followed by chemotherapy combined with immunotherapy can improve pCR rate in patients with pMMR/MSS LARC, and might also provide higher organ preservation rates and long-term survival benefits. The study aims to explore the efficacy and safety of a TNT regimen comprising short-course radiotherapy combined with chemotherapy, cetuximab N01 (for patients with wild-type RAS/BRAF) or bevacizumab (for patients with mutant RAS/BRAF), and sintilimab in patients with high-risk LARC.
Who can participate
Age range
18 Years – 75 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:
* Voluntarily signed the informed consent form.
* Aged 18-75 years (inclusive of 18 and 75 years).
* pMMR/MSS.
* Middle or low rectal cancer located ≤10 cm from the anal verge as assessed by MRI.
* Histopathologically confirmed locally advanced rectal adenocarcinoma and high-risk features confirmed by pelvic MRI (meeting any of the following criteria: clinical stage cT3N+ or cT4N0/+; MRF+ or EMVI+; enlarged lateral pelvic lymph nodes).
* ECOG PS of 0-1.
* Expected survival ≥2 years.
* No prior anti-tumor therapy.
* At least one measurable lesion with a longest diameter ≥10 mm measured by MRI (by RECIST version 1.1).
* Organ functions meeting the following requirements (no blood products or cell growth factors allowed within 14 days prior to enrollment):
Absolute neutrophil count ≥1.5×10⁹/L; Platelet count ≥100×10⁹/L; Hemoglobin ≥90 g/L; Total bilirubin \<1.5×ULN; ALT and/or AST \<2.5×ULN; Serum creatinine \<1.5×ULN; Creatinine clearance ≥50 mL/min.
* Women of childbearing potential must use effective contraceptive measures.
* Good compliance and willingness to comply with follow-up requirements.
Exclusion Criteria:
* Unable to comply with the study protocol or study procedures.
* Patients with contraindications to surgery.
* Patients with metastatic disease or recurrent rectal cancer.
* Uncontrolled active autoimmune disease or active inflammatory disease at enrollment, or receiving immunosuppressive therapy.
* History of organ transplantation.
* Know…
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.