Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT06035133
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 70;
* Histologically confirmed adenocarcinoma of rectum;
* The distance from the lower edge of the tumor to the anus is ≤ 10cm;
* ECOG score ≤ 1;
* Have not received any anti-tumor treatment before;
* Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2; M0 chest and abdomen CT showed no obvious metastasis. (Note: PET-CT is recommended when small nodules can not be identified by liver or lung CT, and can still be included in the group when considering the possibility of metastasis)
* Hematological indicators and liver and kidney function within 7 days are within the normal range;
* Sign the informed consent form and be able to follow the research and /or follow-up procedures.
Exclusion Criteria:
* Have serious basic diseases, such as heart disease, renal failure, severe liver failure or liver failure, coagulation dysfunction, etc; Postoperative recurrence of colorectal cancer;
* The patient had a history of malignant tumor within 5 years;
* Pregnant or lactating women;
* The patient has a history of adjuvant radiotherapy for other system diseases, and surgical contraindications, so it is not suitable for surgery;
* The patient has had radiotherapy and chemotherapy records before this visit;
* Distant metastasis was found during operation;
* Patients with poor radiotherapy compliance and difficult cooperation;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06035133
Study Brief:
Protocol Section:
NCT06035133