Shorter radiation combo may boost rectal cancer remission
NCT ID NCT07469306
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two treatments for locally advanced rectal cancer: a shorter course of radiation plus chemotherapy (CAPOX) and immunotherapy (tislelizumab) versus a longer course of chemoradiation plus the same immunotherapy. The goal is to see which approach leads to a higher rate of complete tumor disappearance. About 130 adults aged 18-75 with a specific type of rectal cancer will participate.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-75 years, any gender. * Pathologically confirmed rectal adenocarcinoma. * Baseline MR stage T3-4/N+. * Distance from anal verge ≤12cm. * No distant metastasis. * Karnofsky Performance Status ≥70. * Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy. * Microsatellite/mismatch repair status MSS/pMMR. * No prior chemotherapy or any other anti-tumor treatment before inclusion. * No prior immunotherapy. * Ability to comply with the study protocol during the study period. * Signed written informed consent. Exclusion Criteria: * Pregnant or lactating women. * Pathological diagnosis of signet ring cell carcinoma. * History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ. * Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication. * Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months. * Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users. * Patients with autoimmune diseases. * Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities. * Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L. * Known deficiency of dihydropyrimidine dehydrogenase (DPD). * Allergy to any investigational drug components.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
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Jinjiang Municipal Hospital
Quanzhou, Fujian, 362200, China
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The Second Hospital of Longyan
Longyan, Fujian, 364000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Butter-Derived supplement protect the gut during cancer radiation?
- Can an immunotherapy cocktail make rectal tumors disappear before surgery?
- Could cutting one amino acid make rectal cancer treatment more effective?
- Can a targeted radiation combo boost rectal cancer remission?
- Can a short burst of radiation plus triple chemotherapy wipe out rectal cancer before surgery?
- MRI-Guided radiation boosts hopes for rectal cancer patients