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Triple threat: new combo therapy targets rare rectal cancer

NCT ID NCT06364384

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sixth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.