colorectal cancer
Conditions
Interventions
experimental group:QL1706 combined with regorafenib or fruquintinib
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. age >= 18 years, gender-neutral; 2. histologically or cytologically confirmed inoperable metastatic colorectal cancer (AJCC 8th stage IV); 3. disease progression during or after second-line standard therapy; 4. no prior use of TKI analogues such as regorafenib, furoquinotinib, etc; 5. at least one imaging measurable lesion according to the Criteria for Evaluation of Efficacy in Solid Tumours (RECIST version 1.1); 6. an ECOG score of 0-2; 7. expected survival >= 3 months; 8. adequate organ function with subjects meeting the following laboratory parameters: 1) Absolute neutrophil count (ANC) >= 1.5x10?/L in the last 14 days without granulocyte colony-stimulating factor. 2) Platelets >= 80 x 10?/L in the last 14 days without transfusion. 3) In the last 14 days without transfusion or erythropoietin use, haemoglobin > 8 g/dL.4) Total bilirubin ULN but direct bilirubin =60 ml/min; 7) Good coagulation function, defined as an international normalised ratio (INR) or prothrombin time (PT) of <=1.5×ULN.8) Normal thyroid function, defined as a thyroid-stimulating hormone (TSH) in the normal range. If baseline TSH is outside the normal range, subjects may also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 9. women of childbearing potential must have had a negative pregnancy test (serum or urine) within 14 days prior to enrolment and voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of study drug; for men, they should be surgically sterilised or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of study drug; 10. patients voluntarily enrol in the study and sign an informed consent form (ICF); 11. It is expected that those with good compliance will be able to follow up the efficacy and adverse effects as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women; 2. prior therapy with the following: PD-L1 monoclonal antibody, PD-1 monoclonal antibody, or an agent targeting another stimulatory or synergistic inhibitor of T-cell receptors (e.g., CTLA-4, OX-40, CD137); 3. any active malignancy within 2 years, with the exception of the specific cancers being studied in this trial and locally recurrent cancers that have been cured (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ); 4. currently being treated in an interventional clinical study or have been treated with another investigational drug or with an investigational device within 4 weeks prior to the first dose; 5. active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating medications, glucocorticoids, or immunosuppressive agents) within 2 years prior to first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic therapy; 6. being on systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; 7. has not fully recovered from any intervention-induced toxicity and/or complications (i.e., <= Grade 1 or at baseline, excluding malaise or alopecia) prior to initiation of treatment; 8. known hypersensitivity to the study drug or excipients, known severe allergic reaction to any of the monoclonal antibodies; 9. known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 10. vaccination with live attenuated vaccine within 4 weeks prior to the first dose or planned for the duration of the study; 11. suffering from uncontrolled cardiac clinical symptoms or disease; 12. have multiple factors that affect the absorption of oral medications; 13. have had gastrointestinal bleeding within 2 weeks prior to enrolment or are at high risk of bleeding as judged by the investigator; 14. concurrent severe infections within 4 weeks prior to first dose; 15. major surgery, open biopsy or significant trauma within 28 days prior to enrolment 16. known history of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation; 17. in the judgement of the investigator, the subject has other factors that may lead to forced termination of this study in the middle of the study, such as non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious abnormalities in laboratory tests, accompanied by family or social factors, which would affect the subject's safety, or the collection of data and samples
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival as assessed by the investigator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective mitigation rate;Disease control rate;Duration of relief;overall survival;safety; | — |
Countries
China
Contacts
Public ContactLiu aina
Yantai Yuhuangding Hospital
Outcome results
None listed