New combo therapy aims to shrink rectal tumors faster
NCT ID NCT07669220
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new treatment approach for high-risk rectal cancer: short-course radiation followed by immunotherapy (toripalimab) and chemotherapy (FOLFOX) versus the standard long-course chemoradiation. The goal is to see if the new approach leads to more complete tumor responses and better long-term outcomes. The trial plans to enroll 76 adults with a specific type of rectal cancer that has not spread widely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab (a PD-1 inhibitor) combined with FOLFOX chemotherapy
- What this could lead to
- If successful, this could offer a more effective and less toxic treatment option for high-risk rectal cancer, potentially reducing the need for major surgery.
- What could go wrong
- This is a small, early-phase (Phase 2) trial with only 76 participants, so results may not apply to everyone. The combination therapy may cause significant side effects, and it's not yet proven to be better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: 1. 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. 2. Age 18-75 years. 3. Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma. 4. The lower edge of the rectal tumor is located below the peritoneal reflection. 5. Locally advanced disease with high-risk factors, meeting at least one of the following: cT4 / cN2 / EMVI+ / MRF+ / positive lateral lymph node. 6. No clear evidence of distant metastasis prior to treatment. 7. No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy). 8. ECOG performance status 0-1 (Appendix 1). 9. Peripheral blood counts and liver and renal function within the following ranges (tested within 15 days before treatment initiation): * White blood cell count (WBC) ≥ 3.0 × 10⁹/L or absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; * Hemoglobin (HGB) ≥ 80 g/L; ③ Platelet count (PLT) ≥ 100 × 10⁹/L; ④ Hepatic transaminases (AST/ALT) \< 3.0 × upper limit of normal (ULN); ⑤ Total bilirubin (TBIL) \< 1.5 × ULN; ⑥ Creatinine (CREAT) \< 1.5 × ULN. 10. No history of other concurrent malignancies; not pregnant or lactating; effective contraceptive methods should be used during the study period and for 6 months after the last dose. Exclusion Criteria: 1. Patients with a history of severe drug allergy (including allergy to platinum agents, 5-FU, and 5-HT3 receptor antagonists). 2. Patients who have participated in or are currently participating in another clinical trial within 4 weeks prior to enrollment. 3. 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. 4. Severe electrolyte abnormalities. 5. 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. 6. 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. 7. 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. 8. 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). 9. Severe electrocardiogram abnormalities, or active coronary artery disease, severe/unstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or congestive heart failure of NYHA Class II or higher. 10. Patients with active infection (infection causing fever \> 38°C). 11. Patients with poorly controlled hypercalcemia, hypertension, or diabetes mellitus. 12. Patients with severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.). 13. Patients with mental disorders affecting clinical treatment or a history of central nervous system disease. 14. Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.). 15. Presence of any unresolved toxicity of CTCAE Grade 2 or higher resulting from prior therapy (except for anemia, alopecia, and skin pigmentation). 16. Any medical condition that is unstable or may affect patient safety and compliance with the study. 17. Patients deemed by the investigator to be unsuitable for participation in this clinical trial.
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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
1 site. 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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The Sixth Affiliated Hospital of Sun Yat-sen University
RECRUITINGGuangzhou, China
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