A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequ… (NCT07669220) | Clinical Trial Compass
RecruitingPhase 2
A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)
China76 participantsStarted 2026-01-01
Plain-language summary
This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk locally advanced pMMR/MSS lower rectal adenocarcinoma, aiming to provide high-level evidence supporting a novel treatment paradigm.
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
. Before implementing any procedures related to the study protocol rather than routine clinical care, a signed and dated informed consent form must be obtained from the subject voluntarily, in accordance with regulatory requirements and institutional guidelines.
. Age 18-75 years.
. Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma.
. The lower edge of the rectal tumor is located below the peritoneal reflection.
. Locally advanced disease with high-risk factors, meeting at least one of the following: cT4 / cN2 / EMVI+ / MRF+ / positive lateral lymph node.
. No clear evidence of distant metastasis prior to treatment.
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.
What they're measuring
1
CCR
Timeframe: 3 years
Trial details
NCT IDNCT07669220
SponsorSixth Affiliated Hospital, Sun Yat-sen University
. No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).
. ECOG performance status 0-1 (Appendix 1).
Exclusion criteria
. Patients with a history of severe drug allergy (including allergy to platinum agents, 5-FU, and 5-HT3 receptor antagonists).
. Patients who have participated in or are currently participating in another clinical trial within 4 weeks prior to enrollment.
. History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other therapy specifically targeting T-cell co-stimulation or checkpoint pathways.
. Severe electrolyte abnormalities.
. Presence of gastrointestinal diseases such as active gastric or duodenal ulcer, ulcerative colitis, or unresected tumor with active bleeding; or other conditions that may cause gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment.
. History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding tendency or hemorrhagic history within 2 months; currently receiving high-dose anticoagulation therapy.
. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test prior to the first dose; or female participants and their partners who are unwilling to practice strict contraception during the study period.
. Presence of other concurrent or prior active malignancies (except for malignancies that have been curatively treated with no recurrence for more than 3 years, or carcinoma in situ that can be cured by adequate treatment).