Colorectal cancer
Conditions
Interventions
Test group:Iparomlimab and Tuvonralimab: 5 mg/kg, IV infusion (ivgtt), every 3 weeks (Q3W)
Molecular-targeted agent(s),To be selected based on patients genetic testing results
mFOLFOX6 Regimen: Oxaliplatin, 85 mg/m^2, IV infusion, Day 1, every 2 weeks (Q2W)
Calcium Folinate (Leucovorin) ,400 mg/m^2, IV infusion, Day 1, Q2W
5-Fluorouracil (5-FU),400 mg/m^2, IV bolus, Day 1, Q2W
Followed by 2400 mg/m^2, continuous IV infusion over 46 hours (Day 1 to Day 2), Q2W
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent form must be obtained prior to any trial-related procedures. 2. Age >= 18 years, male or female. 3. Histologically confirmed unresectable, locally advanced or metastatic colon cancer. 4. No prior systemic anti-cancer therapy for advanced disease. If the patient has recurrent disease, the time from curative resection or (neo)adjuvant therapy must be > 6 months. 5. Must have received at least one prior line of systemic therapy. Adjuvant or neoadjuvant chemotherapy with disease progression within 6 months is considered one line of systemic therapy. Patients whose last dose of approved Chinese patent medicine with anti-tumor indications was completed at least 2 weeks ago are eligible. [Note: This criterion appears to present an alternative scenario to Criterion 4. Please verify the intended logic with the study protocol.] 6. At least one measurable lesion as confirmed by the investigator according to RECIST 1.1. 7. For female patients of childbearing potential, the patient and/or partner agree to use a highly effective method of contraception. 8. Life expectancy >= 3 months. 9. Subjects with hepatitis B virus (HBV) infection who meet the following criteria are also eligible: 1)HBV viral load = 1.5 × 10?/L. b) Platelets >= 75 × 10?/L. c) Hemoglobin >= 90 g/L. d) Serum albumin >= 30 g/L. e) AST and ALT 1.5 × ULN, then creatinine clearance (CLcr) calculated by the Cockcroft-Gault equation must be >= 50 mL/min. h) Left ventricular ejection fraction (LVEF) > 50%. i) Proteinuria = 2+, a 24-hour urine protein quantification should be performed; eligibility requires a result of <= 1g). j) International normalized ratio (INR) <= 1.5; activated partial thromboplastin time (APTT) <= 1.5 × ULN. 12. The investigator judges that the patient can benefit from the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or men or women unwilling to use effective contraception. 2. Patients not suitable for efficacy evaluation per RECIST v1.1? criteria. 3. Individuals with a known allergy to the investigational drug or its active ingredients, or a history of allergy to similar biological agents. 4. Patients with confirmed active tuberculosis (TB), known human immunodeficiency virus (HIV) positive status, or other severe infections requiring treatment. 5. History of immunodeficiency or autoimmune diseases, OR long-term systemic corticosteroid therapy (within 7 days prior to enrollment) or any form of immunosuppressive therapy. 6. History of other concurrent (including unknown primary) malignancies, with the following exceptions: cured non-melanoma skin cancer, carcinoma in situ of the cervix, cured Stage I uterine cancer, cured ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast (not currently receiving any systemic therapy), localized prostate cancer treated with radical surgery and currently considered cured, and other solid tumors treated radically more than 5 years ago with no signs of recurrence. 7. Known central nervous system tumors, including metastatic brain tumors. 8. Presence of any unstable systemic disease, including but not limited to: severe infection, hypertension uncontrolled by antihypertensive therapy, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction (myocardial infarction history >=6 months ago is permitted), congestive heart failure, severe arrhythmia requiring drug therapy, renal or metabolic diseases. 9. Presence of any medical contraindications to undergoing any contrast-enhanced imaging examinations (CT or MRI). 10. Participation in other interventional clinical trials within 30 days prior to screening (Note: Patients already in the follow-up period of a clinical trial may participate in this trial if it has been 4 weeks after the last dose of the previous investigational drug). 11. Any other condition deemed by the investigator as making the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;progression free survival, PFS;disease control rate, DCR;Duration of relief, DOR;adverse event, AE; | — |
Countries
China
Contacts
Public ContactZishu Wang
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed