This is a single-arm, open-label, phase Ib clinical trial to evaluate the efficacy and safety
of TQB2450 combined with anlotinib in subjects with gynecological cancer, including 34
ovarian cancer,34 endometrial cancer,22 cervical cancer.
Inclusion Criteria:
1. Understood and signed an informed consent form;
2. 18 years and older, male or female, Eastern Cooperative Oncology Group (ECOG)
performance status of 0 to 1, life expectancy ≥ 3 months;
3. Histologically confirmed, unresectable recurrent/metastatic advanced gynecologic
cancer, including ovarian, endometrial, and cervical cancer;
4. Subjects have received at least 1 line platinum-containing chemotherapy (minimum of 4
cycles of platinum-containing treatment) after tumor reduction, and meet any of the
following:Platinum-resistant or refractory patients, including patients who have
progressed or relapsed during previous platinum-containing chemotherapy regimens or
within 6 months after the end of platinum-containing chemotherapy;
5. At least one measurable lesion according to the RECIST 1.1;
6. The main organs function are normally;
7. Male or female subjects should agree to use an adequate method of contraception
starting with the first dose of study therapy through 6 months after the last dose of
study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or
breastfeeding women, and a negative pregnancy test are received within 7 days before
the randomization.
Exclusion Criteria:
1. Has other non-epithelial ovarian tumors or borderline ovarian epithelial tumors;
2. Other malignant tumors that have appeared or are currently present within 5 years,
except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial
bladder tumors;
3. Has previously received immune drugs such as PD-1 / PD-L1, CTLA-4 or other tyrosine
kinase inhibitors such as anlotinib hydrochloride;
4. Has received bevacizumab within 28 days before the first dose;
5. Has received chemotherapy, surgery, radiotherapy, the last treatment from the first
dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral
fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for
less than 6 weeks;
6. Expect to use any active vaccine against infectious diseases (such as influenza
vaccine, chickenpox vaccine, etc.) within 28 days before the first dose or during the
study period;
7. Patients diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy
or any other form of immunosuppressive therapy (dose> 10mg / day prednisone or other
effective hormones) and continue to use it within 2 weeks before the first dose;
8. Active autoimmune diseases that require systemic treatment have occurred within 2
years before the first dose;
9. Subjects known to be allergic to the study drug or any of its excipients or have
experienced a severe allergic reaction to other monoclonal antibodies;
10. Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous
meningitis;
11. Has any bleeding or bleeding event ≥ CTC AE Grade 3 or unhealed wounds, ulcers or
fractures within 4 weeks before the first dose;
12. Has clinically significant thyroid dysfunction before the first dose;
13. Has multiple factors affecting oral medication;
14. Has any severe acute complications before the first dose;
15. Has participated in other anti-tumor intervention clinical trials within 4 weeks
before the first medication;
16. According to the judgement of the researchers, there are other factors that may lead
to the termination of the study. For example, other serious diseases including mental
disorders need to be treated together, serious laboratory abnormalities, accompanied
by family or social factors, which will affect the safety of the subjects, or the
collection of data and samples.