Colorectal cancer
Conditions
Interventions
Experimental group:Sulfasalazine combined with fruquintinib and sintilimab
Sponsors
The First Afliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Before implementing any trial-related procedures, sign a written informed consent; 2. Over 18 years old; 3. Histologically confirmed as colorectal adenocarcinoma; 4. Satellite stable (MSS) or low-grade instability (MSI-L) or normal expression of DNA mismatch repair genes (pMMR); 5. ECOG PS score of 0-1; 6. Progression after standard second-line treatment (having received irinotecan, oxaliplatin or fluorouracil-based drugs, including or excluding targeted therapy (bevacizumab, cetuximab, etc.)); 7. Adequate organ and bone marrow functions; 8. Expected survival of more than 3 months; 9. For pregnant women of childbearing age, a urine or serum pregnancy test should be conducted 3 days before the first administration of the study drug (on the first day of the first cycle) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-pregnant women are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Within the past 5 years, had any other malignant tumor, skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ, except for these; 2. Microsatellite instability high (MSI-H) or loss of DNA mismatch repair gene expression (dMMR); 3. Currently participating in an interventional clinical study for treatment, or having received other study drugs or used study devices within 4 weeks before the first administration; 4. Had previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another type of stimulatory or synergistic inhibitory T-cell receptor (such as CTLA-4, OX-40, CD137); 5. Had an active autoimmune disease requiring systemic treatment (such as using disease-modifying drugs, glucocorticoids or immunosuppressants) within 2 years before the first administration. Alternative therapies (such as thyroid hormone, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment; 6. Imaging shows tumor invasion/infiltration of major blood vessels or the investigator or radiologist assesses a bleeding tendency; 7. Had major surgical treatment within 4 weeks before the first study drug administration (except for biopsy-related surgeries) or expected to undergo major surgery during the study; 8. Severe non-healing wound ulcers or fractures; 9. Had minor surgery (outpatient/ inpatient surgery requiring local anesthesia, including central venous catheterization) within 48 hours before the first administration of the study drug; 10. Currently or within the recent period (within 10 days before the first dose of the study drug) using aspirin (> 325 mg/day) or other known non-steroidal anti-inflammatory drugs that can inhibit platelet function continuously for 10 days; 11. Currently or within the recent period (within 10 days before the first dose of the study drug) using full-dose oral or parenteral anticoagulants or thrombolytic agents for treatment; 12. Note: Permissive use of small-dose anticoagulants for prophylaxis: Under the condition of an international normalized ratio (INR) of <= 1.5, it is allowed to use small-dose warfarin (<= 1mg/day), small-dose heparin (<= 12,000 U/day) or small-dose aspirin (<= 100mg/day) for prophylactic purposes; 13. Has a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis; 14. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 15. Known to be allergic to the active ingredients of this study drug, or bevacizumab or dexethalamide; 16. Before starting treatment, has not fully recovered from any toxicity or complications caused by any intervention (i.e., <= 1 grade or reaching baseline, excluding fatigue or hair loss); 17. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibody); 18. Un-treated active hepatitis B (defined as HBsAg positive while detecting HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center where the test is conducted); 19. Pregnant or lactating women; 20. Any severe or uncontrollable systemic disease; History or disease evidence, treatment or laboratory test values that may interfere with the test results, prevent the subject from fully participating in the study throughout, or abnormal values, or the investigator considers other situations that are not suitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival period;Duration of relief;Disease control rate;Progression-free survival period; | — |
Countries
China
Contacts
Public ContactTai Ma
The First Afliated Hospital of Anhui Medical University
Outcome results
None listed