๐ฌIn plain words
What the trial is, and whether it could suit you
A Phase II, open label, non-randomized, multiple-arm, single-center clinical trial in patients with advanced rare solid tumors who failed to standard treatment.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Male or female, the age at the time of signing the informed consent is no less than 18 years old;
2. Patients with advanced or metastatic rare solid tumor confirmed by histological confirmed;
3. ECOG score is 0 or 1; ECOG score needs to be evaluated 7 days before the first treatment;
4. Expected survival โฅ12 weeks;
5. According to Response Evaluation Criteria in Solid Tumor (RECIST 1.1), there is at least one imaging measurable lesions, which has obvious disease progress before radiotherapy or after radiotherapy;
6. Within the scope of CMPA approved drug indications, the disease has progressed after the standard treatment recommended by NCCN or CSCO guidelines (if there is standard treatment, the recommended level is IA-IIA), or there is no standard effective treatment plan, or it is no longer suitable for standard anti-tumor treatment, or the patients refuse the standard treatment plan;
7. Fresh biopsy tissue samples (obtained within 12 weeks before the first use of the drug, 4 pieces of coarse needle biopsy must be provided, and no other anti-tumor treatment, systemic anti infection treatment, vaccination, et al.) and peripheral blood samples must be provided for molecular typing;
8. Must have a primary or metastatic paraffin specimen (without radiotherapy) other than bone metastatic lesions before enrollment (within 2 years, 15-20 sheets, 4-6ฮผm thick white slices, of which 5 need to be glued and baked ). If requirements are not met, investigator are allowed the decision to enroll subjects according to the specific situation.
9. If there is pleural or peritoneal effusion, the specimens must be taken for pathological cytological examination of which 300 ml samples must be provided;
10. In the condition that the primary lesions biopsy specimen has been provided, if the metastatic lesion is able to be biopsied, it is suggested to keep the specimen for pathological testing and provide fresh tissue specimen (optional); when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mutation, C-KIT mutation, HER-2 mutation HER-2 over expression/amplification, CDKN2A mutation patients will enroll in corresponding sub-study of targeted therapy; if no above mentioned actionable mutation is identified, patients will enroll immunotherapy sub-study. (Each sub-study has separate inclusion and exclusion criteria besides general ones)
11. After the progression of the subject's disease, if conditions permit, fresh tissue samples shall be obtained from the same biopsy lesions and the metastasis lesions of the previously obtained samples;
12. Toxic and side effects caused by previous treatment need to be restored to โค Grade 1 or returned to the baseline value (NCI-CTCAE version 5.0, except for hair loss);
13. Negative pregnancy test (only applicable for women with childbearing potential). No childbearing potential is defined as being postmenopausal for longer than one year or having undergone surgical sterilization or hysterectomy. All patients (male and female) agree to use an effective form of contraceptive measures and continue its use for the duration of treatment and within 8 weeks after the end of treatment;
14. Signed, written informed consent of volunteers that join the group shall follow the study treatment plan, follow-up plan and cooperate to observe the adverse events and efficacy.
Exclusion Criteria:
1. History of PD-1 / PD-L1 drug treatment.
2. History of the targeted drug treatment of this study.
3. Allergies towards drug ingredients or excipients in this study.
4. History of interstitial lung disease or radiation pneumonitis of any type.
5. Central Nervous System (CNS) metastases with brain metastases-related symptoms, which is not stable in neurology, or need to increase steroid dosage to control CNS disease. (Note: Patients with controlled CNS metastasis are eligible to participate in this study. Before entering the study, subject must have completed radiotherapy or CNS tumor metastasis surgery for more than fourteen days, neurological function must be in a stable state with no new neurological defects found in the clinical examination and no new problems found in the CNS imaging examination. If necessity arises for subjects to use steroids for CNS metastases treatment, said steroid treatment dose must have reached stable treatment for โฅ 3 months at least two weeks before entering the study.
6. Current uncontrollable third cavity effusion, such as a large amount of pleural effusion or ascites.
7. Unmeet the inclusion criteria of sub scheme.
8. Major surgical operations or incomplete healing of injury within 28 days prior to study treatment's first administration and chest radiotherapy of \> 30 Gy within 6 months.
9. History of receiving other investigational drugs within 14 days or 5 half-lives (whichever is longer) prior to the first administration.
10. History of receiving live vaccine within 30 days prior to the first administration. Seasonal influenza vaccines that do not contain live viruses are allowed.
11. History of hypersensitivity to the active ingredients or non-active excipients of the study drug, hypersensitivity to drugs with chemical structure similar to the study drug or hypersensitivity to similar drugs of the study drug.
12. Current 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 the number of HBV DNA copies exceeds the upper limit of normal value, or HCV AB positive;
3. Active tuberculosis (with exposure history or positive tuberculosis test; with clinical and / or imaging manifestations);
4. Positive antibody of Treponema Pallidum.
13. Current evidenced uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated