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:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT05300269
Eligibility Criteria:
Inclusion Criteria:
1. Be willing and able to provide written informed consent for the trial.
2. Locally advanced rectal adenocarcinoma and was evaluated as resectable ;
3. The inferior margin of the tumor ≤ 10 cm from the anal verge ;
4. No prior anti-cancer treatment for rectal cancer;
5. Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
6. Adequate hematologic and end-organ function;
7. Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug
Exclusion Criteria:
1. Unresectable disease determined by investigators
2. Recurrent rectal cancer
3. Evidence of metastatic disease or lateral lymph node metastases
4. Presence of synchronous colorectal cancer
5. Presence of obstruction or imminent obstruction
6. Not eligible for long-course radiotherapy
7. Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled
8. Prior malignancy within the prior 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical/breast cancer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05300269
Study Brief:
Protocol Section:
NCT05300269