Gynecological oncology
Conditions
Interventions
Experimental group:Anlotinib combined with TQB2450
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Eligible patients must meet all of the following criteria: 1. Patients who have signed written informed consent before implementing any trial related process; 2. Patients with age >= 18 years old and <= 75 years old; 3. Patients with locally advanced (stage III), metastatic or recurrent (stage IV) gynecologic malignant tumor (FIGO stage) confirmed by histology or cytology and unable to undergo surgery or radical concurrent chemoradiotherapy; 4. The patients who were confirmed by histology were not suitable for brac1 / 2 targeted therapy (no brac1 and brac2 gene mutation); 5. Sufficient qualified tumor tissues were provided. PCR was used to detect MSI patients, or IHC was used to detect the expression of MMR and PD-L1; 6. According to RECIST 1.1, there was at least one measurable lesion. The lesions located in the field of previous radiotherapy can be regarded as measurable lesions if their progression is confirmed.
Exclusion criteria
Exclusion criteria: 1. Patients with active bleeding within 2 weeks before drug administration in the first study; 2. Patients who received radiotherapy before drug administration in the first study met one of the following conditions: (1) More than 30% of bone marrow had been treated with radiotherapy within 14 days before treatment (2) The patients received radiotherapy for the lesion within 6 weeks before treatment and the dose was > 30Gy (the subjects must recover from the toxicity of previous radiotherapy to grade 1 or below without glucocorticoid treatment) (3) The end time of palliative radiotherapy was within 7 days before administration of the first study drug; 3. Patients who had received major surgical treatment within 3 weeks after drug administration in the first study (except for surgery for biopsy purposes); 4. Patients diagnosed with other malignant diseases other than gynecological malignancies within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and / or carcinoma in situ after radical resection); 5. Patients who are currently participating in the intervention clinical research treatment, or have received other research drugs or used research instruments within 4 weeks before the first administration; 6. Patients who have previously received anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs targeting another stimulator or synergistic inhibitor of T-cell receptors (e.g., CTLA-4, OX-40, CD137).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate;Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;DOR;OS; | — |
Countries
China
Contacts
Public ContactJing Guo
Shanghai Tenth People's Hospital
Outcome results
None listed