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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT05690035
Eligibility Criteria:
Inclusion Criteria:
* 18-80 years old (including 18 and 80);
* Histologically confirmed colorectal adenocarcinoma and biopsy pathology confirmed MSS/pMMR;
* Gene testing confirmed ARID1A gene mutation (nonsynonymous);
* No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal colostomy;
* Has received and failed ≥ 2 line of chemotherapy or progressed on or intolerable to oxaliplatin, irinotecan and fluorouracil chemotherapy after diagnosed with mCRC;
* ECOG PS 0-2;
* Able to swallow tablets;
* Life expectancy of greater than 3 months;
* Adequate bone marrow and organ function;
* If female and of childbearing potential, must:
* Have a negative pregnancy test ≤14 days prior to initiating study treatment
* Agree to avoid pregnancy during and for 3 months after study treatment
If male with a partner of childbearing potential, must:
* Agree to use adequate, medically approved, contraceptive precautions during and for 3 months after the last dose of study treatment.
* Able and willing to provide written informed consent for the study.
Exclusion Criteria:
* Any active autoimmune disease or history of autoimmune disease;
* Those who are using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purpose, and continue to use within 2 weeks before enrollment;
* Severe allergic reaction to other monoclonal antibodies;
* Subjects with clinical symptoms of untreated active brain metastasis or meningeal metastasis;
* Have received other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1 in the past;
* Patients with high TMB (≥ 30Muts/Mb) and germline or somatic POLE/POLD1 gene mutations in the exonuclease domain;
* There are clinical symptoms or diseases of heart that are not well controlled, such as: (a) heart failure of NYHA level 2 or above (b) unstable angina pectoris (c) myocardial infarction occurred within 1 year (d) clinically significant supraventricular or ventricular arrhythmia needs treatment or intervention;
* Known hereditary or acquired bleeding and thrombophilia or being treated with thrombolysis or anticoagulation;
* Urinary protein ≥ ++, or the 24-hour urine protein quantification greater than 1.0g;
* Clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment;
* Subjects with active infection;
* Congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B: HBsAg positive and HBV DNA ≥ 10\^4 copies/ml; hepatitis C: HCV antibody positive);
* Other advanced malignant tumors within 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ, ovarian cancer, thyroid cancer and breast cancer);
* Live vaccine may be inoculated less than 4 weeks before the study medication or during the study period;
* Known or suspected to be allergic to the study drug or to any drug given in this trial;
* Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not eligible according to the judgment of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05690035
Study Brief:
Protocol Section:
NCT05690035