Colorectal cancer
Conditions
Interventions
Experimental group:Treatment of metastatic MSS/pMMR colorectal cancer
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age: >= 18 years old; 2. Metastatic MSS/pMMR colorectal cancer confirmed by pathology (including histology or cytology); 3. At least one measurable lesion was present on CT/MRI according to RECIST 1.1 criteria; 4. Prior treatment with fluorouracil, oxaliplatin, or irinotecan based chemotherapy, and prior treatment with anti-VEGF or anti-EGFR (RAS wild type), or unsuitable treatment with irinotecan; 5. Have not received regorafenib or rhatitrexed treatment; 6.ECOG PS: 0-1 score; 7. Expected survival >= 3 months; 8. Impairment from other treatments had been recovered at the time of enrollment, with an interval of >= 6 weeks between nitroso and mitomycin;Receiving other cytotoxic drugs, radiotherapy or surgery for at least 4 weeks before taking regorafenib, and the wound has fully healed; 9. The following criteria were met if the major organs were functioning normally at the time of enrollment: (1) The standard of blood routine examination must meet: (no blood transfusion within 14 days) a. HB>= 90g/L, b. ANC>= 1.5×10^9/L, c. PLT>= 80×10^9/L; (2) Biochemical examination shall meet the following standards: D.il 50ml/min (Cockcroft-Gault formula); 10. Women of reproductive age at the time of enrollment must have had a pregnancy test (serum) within 7 days prior to treatment with a negative result and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose;For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the trial and 8 weeks after the last dose; 11. Subjects voluntarily joined the study, signed informed consent, and cooperated with follow-up.With my consent and signed informed consent, I am willing and able to comply with planned visits, research treatments, laboratory tests and other test procedures.
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent suffering from other malignant tumors; 2. Proven allergic to regorfenib, rhatitrexed and/or ICIs excipients; 3. Immunotherapy overprogression or discomfort in front-line treatment and immunotherapy; 4.HIV infection, HCV infection and other clinically serious infections; 5. Patients with hypertension who cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 6. The patient had severe cardiac insufficiency, and the investigator judged that the patient was not suitable for inclusion; 7. Patients with positive urine protein (urine protein detection of 2+ or more, or 24-hour urine protein quantity >1.0g); 8. Have multiple factors that affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 9. Patients with a clear tendency to gastrointestinal bleeding, including the following conditions: locally active ulcer lesions, and stool occult blood (++);Patients with a history of black stool and hematemesis within 2 months;For patients with fecal occult blood (+) and the primary lesion of gastric tumor that was not surgically removed, the researchers considered that there was a high risk of bleeding, gastroscopy was required, and the main investigators of each center thought that massive gastrointestinal bleeding might occur; 10. Patients who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 11.Patients who have participated in clinical trials of other drugs within 4 weeks; 12. Patients with severe unhealed wounds or fractures, major surgery within 4 weeks of enrollment, and organ transplant history; 13. Receiving other anti-cancer treatments during the study period; 14. Radiotherapy 3 weeks prior to initiation, bone marrow transplantation 4 months prior to initiation, and biological response modulators within 3 weeks prior to initiation. 15. Patients with other concomitant diseases that, in the judgment of the investigator, endanger the patient's safety or interfere with the patient's completion of the study. 16. Patients with symptomatic central nervous system metastasis; 17. Pregnant or lactating women; 18. Those deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR);Disease Control Rate (DCR);Serious Adverse Events (SAE);Adverse Events (AE);Overall survival,OS;Objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactYang,yanan
Army Medical Center of PLA
Outcome results
None listed