Triple threat: new combo therapy targets rare rectal cancer
NCT ID NCT06364384
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests whether adding an immunotherapy drug (PD-1 antibody) to standard chemoradiation can improve outcomes for people with a rare type of rectal cancer called squamous cell carcinoma. About 20 adults with newly diagnosed, non-spread cancer will receive the combination. The main goal is to see how many are cancer-free after 3 years.
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jun 2029
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign the informed consent; 2. 18-75 years old; 3. Patients with pathologically confirmed rectal squamous cell carcinoma; 4. imaging to rule out distant metastases; 5. Peripheral blood and liver and kidney function before treatment within the following allowable limits (tested within 14 days before the start of treatment) 1. White blood cell (WBC) ≥ 3.0×109/L or neutrophil (ANC) ≥1.5×109/L; 2. Hemoglobin (HGB) ≥80 g/L; 3. Platelets (PLT) ≥ 100×109/L; 4. Hepatic transaminases (AST/ALT) \< 3.0 times the upper limit of the normal range; 5. Total bilirubin (TBIL) \< 1.5 times the upper limit of the normal range; 6. Creatinine (CREAT) \< 1.5 times the upper limit of the normal range. 6. ECOG performance status score of 0-2; 7. No history of other malignant tumors in the past. Exclusion Criteria: 1. Non-treatment-naïve patients who have previously received chemotherapy, radiotherapy or complete surgical resection of rectal squamous cell carcinoma; 2. Distant metastases (M1) confirmed by whole-body CT, MR, or PET-CT (including at least the chest, abdomen, and pelvis); 3. Previous or concurrent presence of other active malignancies (except for malignant tumors that have received curative therapy and have been disease-free for more than 3 years or carcinoma in situ that can be cured by adequate treatment); 4. Major surgery such as laparotomy, thoracotomy, resection of organs by laparoscopic surgery or severe trauma within the past 4 weeks (the surgical incision should be completely healed before randomization); 5. Active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to enrollment in the study; 6. Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis within the past 6 months; 7. New York Heart Association (NYHA) Class II or above congestive heart failure; 8. Prior receipt of any investigational drug; 9. Pregnant or lactating women; 10. Any medical condition that is unstable or would affect patient safety and their compliance with the study; 11. Patients judged by the investigator to be unsuitable to participate 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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Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.