rare cancer
Conditions
Interventions
experimental group:camrelizumab in combination with apatinib
Sponsors
Shanghai cancer center, Fudan university
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form; 2. Age = 18 years old; 3. Diagnosed through histological and/or cytological examination, combined with imaging or ultrasound evaluation, as a corresponding rare late stage tumor; 4. ECOG score: 0-1; 5. At least one measurable lesion (according to RECIST standards, non lymph node lesions have a CT scan length of = 10 mm, and lymph node lesions have a CT scan length of = 15 mm); Or it could be a skin infiltration lesion. 6. Blood routine: Absolute Neutrophil Count (ANC) 1.5 × 109/L, Platelet (PLT) = 70 × 109/L, Hemoglobin (HGB) = 80g/L; 7. Liver function: Total bilirubin (TBIL) = 1.5 x Upper Limit of Normal Value (ULN); Alanine Aminotransfer (ALT) and aspartate transfer (AST) = 3 × ULN, and in the presence of liver metastasis, both AST and ALT = 5.0 ULN; Serum albumin = 28 g/L8 Renal function: Serum creatinine (Cr) = 1.5 × ULN, or creatinine clearance rate = 50mL/mi (using the standard Cockcroft Gault formula): 9. Coagulation function: International Normalized Ratio (INR) = 1.5/PT = 1.5 x ULN, aPTT = 1.5 x ULN; If the subject is receiving anticoagulant treatment, as long as PT and INR are within the range of anticoagulant drugs. 10. Estimated survival time = 3 months; 11. It is necessary to use a medically approved contraceptive method during the research treatment period and at least 120 days after the end of the study, and during this period, it is not allowed to donate sperm to others or freeze it for fertilization and reproduction. 12. Able to comply with research visit schedules and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects with any severe and/or uncontrolled diseases. include: 1) Poor blood pressure control (systolic blood pressure = 150mmHg or diastolic blood pressure = 100mmHg); Poor control of diabetes (fasting blood glucose [FBG]>10mmol/L); 2) Suffering from = grade 2 myocardial ischemia or infarction, arrhythmia (QTc = 470ms), and = grade 2 congestive heart failure (New York Heart Association [NYHA] classification); 3) Active or uncontrolled severe infections (= CTCAE level 2 infection) that require systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. 4) Have a history of active tuberculosis; 5) Uncontrollable conditions still require repeated drainage, resulting in ascites, pericardial effusion, and pleural effusion; 2. Active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA = 2000 IU/ml or = 104 copies/ml; hepatitis C reference: HCV RNA = 2000 IU/ml or = 104 copies/ml; after nucleotide antiviral treatment, it is lower than the above criteria, it can be included in the group); Chronic carriers of hepatitis B virus, HBV DNA<104 IU/ml, During the trial, antiviral treatment must be received simultaneously before enrollment can be made; 3. Individuals who have undergone significant surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of the study treatment; Or there may be long-term unhealed wounds or fractures; 4. Individuals who have experienced severe hypersensitivity reactions after using monoclonal antibodies; Individuals who are known to be allergic to the active ingredients or excipients of the drug in this study; 5. Individuals who are currently participating or have participated in other clinical studies within the first 4 weeks prior to the start of the study 6. Individuals with a history of severe allergies; 7. There is a risk of bleeding, coagulation dysfunction, or undergoing thrombolytic therapy; 8. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 9. According to the judgment of the researcher, there is a serious risk to the safety of the subjects or a comorbid disease that affects the completion of the study, or there are subjects who are deemed unsuitable for enrollment due to other reasons. According to the judgment of the researcher, there is a serious risk to the safety of the subjects or a comorbid disease that affects the completion of the study, or there are subjects who are deemed unsuitable for enrollment due to other reasons. Has a clear history of neurological and psychiatric disorders, such as dementia, epilepsy, or susceptibility to seizures; 10. According to the judgment of the investigator, there are serious factors endangering the safety of the subject, or accompanying diseases (such as serious diabetes, thyroid disease and psychosis) that affect the completion of the study, or there are serious and/or unstable medical, mental or other conditions (including laboratory examination abnormalities) that affect the safety of the patient or affect the patient to provide informed consent, or there are any psychological, family, sociological or geographical conditions that affect the research program and follow-up plan; 11. The researcher considers it unsuitable to participate in this clinical trial for any reason;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR ; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS ;OS;Quality of life;Safety and tolerability; | — |
Countries
China
Contacts
Public Contactsheng zhang
Shanghai cancer center, Fudan university
Outcome results
None listed