Could a drug combo replace radiation for rectal cancer?
NCT ID NCT07127497
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 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. 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; \-
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Neoadjuvant chemoimmunotherapy are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Immunotherapy added to standard treatment aims to save the anus in Ultra-Low rectal cancer
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- Can digital surveys capture the full toll of rectal cancer treatment?
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can a platform trial match the right drug combo to each tumor?