colorectal cancer
Conditions
Interventions
Experimental Group:drug therapy
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signed the informed consent form. 2.Aged between 18 and 75 years old (inclusive). 3.Histologically or cytologically confirmed locally advanced unresectable recurrent or metastatic colorectal adenocarcinoma (excluding adenosquamous carcinoma, mixed type and other pathological types). 4.Subjects have failed second-line and above standard systemic therapy. 5.Have at least one measurable lesion according to RECIST version 1.1 criteria. 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. 7.Have adequate organ and bone marrow function, with laboratory examinations meeting the following criteria within 7 days prior to the first administration (no blood components, hematopoietic growth factors, albumin, or other corrective medications deemed by the investigator received within 14 days before laboratory tests). 8.Expected survival time >= 12 weeks.
Exclusion criteria
Exclusion criteria: 1.Previous treatment with anti-PD-1, PD-L1 or CTLA-4 antibodies, or trifluridine/tipiracil. 2.Participants with microsatellite instability-high (MSI-H) colorectal cancer. 3.Received systemic anti-cancer therapy within 14 days or less than 5 half-lives (whichever is shorter) prior to the first dose of study treatment. 4.Received any investigational drug within 4 weeks before the first administration of study drug. 5.Underwent radiotherapy within 4 weeks prior to the first dose. 6.Patients who received radiotherapy more than 4 weeks before the first dose and have any radiotherapy-related toxicities, such as radiation pneumonitis, radiation hepatitis, radiation enteritis, including those with clinical symptoms or requiring glucocorticoid therapy. 7.Known history of primary immunodeficiency. 8.Used systemic immunosuppressive drugs within 28 days before the first dose; exceptions include intranasal, inhaled or other local routes of treatment, or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day prednisone or equivalent) used for no more than 7 days. 9.Received systemic immunostimulatory agents within 28 days prior to the first dose, including but not limited to interferon, interleukin-2, Bacillus Calmette-Guérin (BCG), etc. 10.Underwent major surgical operation (craniotomy, thoracotomy or laparotomy) within 28 days before the first dose, or have severe unhealed wounds, ulcers or fractures judged by the investigator during the screening period. 11.Received or planned to receive live vaccines within 28 days prior to the first dose or during the trial period. Seasonal inactivated influenza vaccines or COVID-19 vaccines without live components are permitted. 12.Unresolved toxicity from previous anti-tumor therapy that has not recovered to CTCAE Grade =1 before the first dose (excluding alopecia, skin pigmentation and other toxicities judged by the investigator to have no safety risks, or toxicities with stable disease outcome; neurotoxicity recovered to CTCAE Grade =2 is allowed for enrollment). 13.Diabetes with poorly controlled blood glucose assessed by the investigator within 7 days before the first dose. 14.evere malnutrition requiring parenteral nutritional support; excluding malnutrition corrected more than 4 weeks prior to the first dose. 15.Known symptomatic and untreated central nervous system metastasis and/or leptomeningeal metastasis. Patients with previously treated brain metastasis (such as surgery, radiotherapy, etc.) are eligible if all of the following are met: i. No imaging evidence of new or enlarged brain metastasis more than 4 weeks before the first dose; ii. Neurological symptoms have recovered to CTCAE Grade <=1 and no steroid therapy is required more than 2 weeks before the first dose. 16.Uncontrolled or significant cardiovascular diseases. 17.Cerebrovascular accident occurred within 6 months prior to the first dose, including cerebral hemorrhage, cerebral infarction (asymptomatic lesions only shown on imaging without clinical symptoms and requiring no treatment are allowed for enrollment), transient ischemic attack, etc. 18.Severe thromboembolic events (such as any arterial thrombotic event, pulmonary embolism, deep vein thrombosis, etc.) occurred within 6 months before the first dose. 19.Medical history of gastrointestinal perforation and/or fistula, peptic ulcer, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), Crohn’s disease within 6 mont
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Objective response rate;Overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactQianyun He
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed