Could a drug combo replace radiation for rectal cancer?

NCT ID NCT07127497

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a combination of chemotherapy and an immunotherapy drug (sintilimab) can effectively treat locally advanced rectal cancer without the need for radiation. The goal is to shrink or eliminate tumors before surgery, potentially preserving organ function. The trial involves 50 adults with a specific type of rectal cancer who cannot tolerate or wish to avoid radiotherapy.

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 50 people

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

Started

Jun 2022

Expected to finish

Oct 2028

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 85 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. Pathologically confirmed rectal adenocarcinoma (non-special type and special type, including mucinous adenocarcinoma, signet ring cell carcinoma, serrated adenocarcinoma, micropapillary carcinoma, medullary carcinoma, cribriform comedo adenocarcinoma); preoperative imaging confirmed that the stage is 1) rectal cancer T3 and (or) N+ resectable rectal cancer patients; 2) for T4 patients, re-evaluation of resectability must be conducted after the completion of neoadjuvant therapy, and radiotherapy may be used in combination depending on the situation. 2. Age ≥ 18 years old, gender is not limited, ECOG score 0-2 points; 3. Physical condition and organ function allow for major abdominal surgery/4. Agree that the researchers use blood, stool and pathological sections for research during the study; 5. Major organ function meets the following requirements (laboratory test values within 7 days before enrollment must meet the following standards) ① Routine blood examination: (no blood transfusion, no use of granulocyte colony stimulating factor, no use of drug correction within 14 days before screening): a) Neutrophil ≥ 1.5×109/L; b) Platelet ≥ 75×109/L; c) Hemoglobin ≥ 90g/L; ② Biochemical examination: (no albumin transfusion within 14 days before screening): a) Serum creatinine ≤ 1.5×upper limit of normal (ULN), or creatinine clearance\> 50 mL/min; b) Serum total bilirubin ≤ 1.5×ULN; c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; ③ Coagulation function: a) International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeds the normal control range ≤ 6 seconds. 6. Patients are recruited regardless of their programmed death ligand 1 (PD-L1) expression level. - Exclusion Criteria:1) The tumor has distant metastasis or peritoneal metastasis confirmed by laparoscopy; 2) Patients with other severe immunosuppressive diseases or other malignant tumors; 3) Any condition that affects the intestinal absorption of capecitabine; 4) Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; severe mental illness; severe respiratory diseases; severe liver and kidney dysfunction; history of unstable angina or myocardial infarction within 6 months; history of cerebral infarction or cerebral hemorrhage within 6 months; continuous use of glucocorticoids within 1 month (except local application); 5) The researcher determines that the patient has other complications that endanger the patient's safety or may affect the completion of the study; 6) Currently or previously received other research drugs or any immunotherapy; 7) Suffering from malignant tumors in other parts within five years; 8) The patient is pregnant or lactating; \-

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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.

Contacts and locations

Locations

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022, China

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