Rare Tumors
Conditions
Interventions
EGFR 19/21/T790M:Almonertinib, 110mg, qd
EGFR 19/21:Dacomitinib, 450mg, qd
ALK:Alectinib, 600mg, bid
ALK:Crizotinib, 250mg, bid
experimental group 5:Zelboraf, 960mg, bid
BRCA:Niraparib,200-300mg,qd
experimental group 7:Pyrotinib, 400mg, qd
experimental group 8:Imatinib, 400mg, bid
experimental group 9:Palbociclib, 125mg,*21d, q28d
experimental group 10:Sintilimab, 200mg, q21d
experimental group 11:Atezolizumab, 1200mg, q21d
experimental group 12:atezolizumab, 1200mg, q21d
experimental group 13:atezolizumab, 1200mg, q21d
Sponsors
National Cancer Center/National Clinical Research Center for Cancer / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria: 1. Male or female, whose age at the time of signing the informed consent is greater than or equal to 18 years old; 2. Patients with advanced or metastatic rare solid tumors confirmed by histological examination (Appendix 1 types of rare solid tumors); 3. Subjects with ECoG score of 0 or 1 (see Appendix 2 for scoring criteria); ECoG score should be evaluated 7 days before the first treatment; 4. The expected survival time was more than 12 weeks; 5. According to RECIST 1.1 evaluation standard of solid tumor efficacy, patients with at least one lesion that can be measured by imaging have obvious disease progression before radiotherapy or after radiotherapy; 6. Within the scope of drug indications approved by CMPA, after the standard treatment recommended by NCCN or CSCO guidelines (if there is standard treatment, the recommended level is Ia-IIa), the disease progresses, or there is no standard effective treatment, or it is no longer suitable for standard anti-tumor treatment, or the patient refuses the standard treatment; 7. Fresh biopsy tissue samples (obtained within 12 weeks before the first medication, 3 pieces of thick needle biopsy, and no other anti-tumor treatment, systemic anti infection treatment, vaccination, etc.) and peripheral blood samples must be provided for molecular typing and inclusion screening; 8. Paraffin tissue samples (15-20 pieces, 4-6 µ m thick white films, 5 of which need to be baked with glue) of primary focus and metastatic focus (without radiotherapy) outside the bone metastases before entering the group must be provided. If they do not meet the requirements, the researcher can decide whether to enter the group according to the specific situation; 9. In case of pleural and peritoneal effusion, specimens must be taken for pathological cytology test, and 300ml samples must be provided; in case of pleural and peritoneal effusion when the disease progresses out of the group, specimens must be taken for pathological cytology test, and 3000ml samples must be provided; 10. If biopsy of the primary lesion has been provided, if biopsy of the metastatic lesion can be performed (according to the judgment of the researcher), it is recommended to reserve specimens for pathological examination and provide fresh tissue samples; 11. If conditions permit (judged by the researcher), fresh tissue samples should be obtained from the same biopsy focus and the metastatic focus of the previously obtained samples at the time of enrollment, if the disease progresses; 12. Adverse reactions caused by previous treatment should be restored to <= 1 grade or return to baseline value (nci-ctcae version 5.0, except hair loss); 13. Negative pregnancy test (only applicable to women with possibility of pregnancy). No possibility of pregnancy was defined as at least 1 year after menopause, or surgical sterilization or hysterectomy. 14. All patients (male or female) agreed to take contraceptive measures during the whole treatment period and within 8 weeks after the end of treatment; 15. The volunteers who signed the informed consent followed the trial treatment plan and visit plan, and could cooperate to observe the adverse events and curative effect.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following exclusion criteria were not allowed to participate in this study: 1. There are other potential targets, including but not limited to: RET fusion, ntrk1 / 2 / 3 fusion, FGFR amplification / fusion, as determined by the researcher. 2. Patients who have received PD-1 / PD-L1 drugs in the past. 3. Patients who have received targeted drug therapy of this study. 4. Those subjects who are known to be allergic to the drug ingredients or excipients in this study. 5. Patients with any type of interstitial lung disease or radiation pneumonitis. 6. Patients with brain metastasis related symptoms and neurologically unstable central nervous system (CNS) metastasis, or need to increase steroid dose to control CNS disease. (Note: patients whose CNS metastasis has been controlled can participate in this trial. Before entering the study, patients must have completed radiotherapy or at least two weeks after surgery for CNS tumor metastasis. The patient's neurological function must be in a stable state. No new neurological deficit was found in clinical examination, and no new problems were found in CNS imaging examination. If patients need to use steroids to treat CNS metastases, their steroid treatment dose has reached stable treatment for at least two weeks before entering the study, and stable for at least 3 months). 7. Patients with uncontrollable third cavity effusion, such as massive pleural effusion or ascites. 8. Subjects that do not conform to the inclusion criteria of sub schemes. 9. Subjects who had undergone major surgery or whose wound had not healed completely within 4 weeks before the first administration; subjects who received > 30 Gy chest radiotherapy within 6 months before the first administration. 10. Received other research drugs 14 days or 5 half lives before the first administration, whichever is longer. 11. Subjects vaccinated with live vaccine within 30 days before the first administration. Seasonal influenza vaccine without live virus is allowed. 12. Patients with a history of hypersensitivity to the active ingredients or inactive excipients of the study drug, drugs with chemical structure similar to the study drug or similar drugs of the study drug. 13. Active infection requiring systemic treatment (antibiotics); or any of the following: (1) HIV positive or known history of acquired immunodeficiency syndrome; (2) Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection is defined as HBsAg positive and HBV DNA copy number exceeds the upper limit of normal value, or HCV AB positive; (3) Subjects with active TB (with exposure history or positive TB test; with both clinical and / or imaging manifestations); (4) Treponema pallidum antibody was positive. 14. Evidence of patients with severe or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or decompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE 3 after drug treatment]). 15. Patients with myocardial infarction, coronary artery bypass grafting or cerebrovascular accident within 15.3 months. 16. Patients diagnosed with a second malignancy within 5 years before the first diagnosis of rare solid tumors (excluding completely resected basal cell carcinoma, bladder carcinoma in situ and cervical carcinoma in situ). 17. Patients who have received any organ transplantation, including allog
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR assessed by BICR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (RECIST 1.1) and iPFS (iRECIST) in the single drug immunotherapy group assessed by Blinded Independent Central Review and investigator;PFS2;Six-months Progression-Free Survival of Monotherapy (iPFS) in the immunotherapy group assessed by Blinded Independent Central Review and investigator;DOR;DCR;DCB;one year OS rate;OS;AE;patient outcome; | — |
Countries
China
Contacts
Public ContactLi Ning
Cancer Hospital of Chinese Academy of Medical Sciences
Outcome results
None listed