Cervical cancer
Conditions
Interventions
Anlotinib combined with chemotherapy group:Anlotinib+Cisplatin/Paclitaxel
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old when signing the informed consent form; 2. ECOG score 0-2 points; 3. The expected survival period is not less than 3 months, with measurable lesions; 4. Recurrent or metastatic cervical cancer patients who have received one-time systemic treatment in the past, and first-line patients with newly treated metastatic cervical cancer (FIGO IVB stage), including squamous cell carcinoma, adenocarcinoma and squamous carcinoma; 5. Have not received any form of anti-tumor treatment within one month before treatment (including: any form of chemotherapy, radiotherapy and traditional Chinese medicine treatment, etc.); 6. The main organs function well; 7. Women of childbearing age must undergo a serum pregnancy test within 3 days before the first medication, and the result is negative. Female subjects of childbearing age must agree to use high-efficiency methods of contraception during the study and within 180 days after the last administration of the study drug; 8. Volunteer to join the study, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Suffer from other tumor-related symptoms and treatments, or combined with other major diseases; 2. Participated in any other drug clinical research within 4 weeks before randomization, or no more than 5 half-lives from the last study drug; 3. The subject is known to have a history of psychotropic drug abuse, alcohol abuse or drug abuse; 4. Female subjects who are pregnant, lactating or planning to become pregnant during the study period; 5. According to the judgment of the investigator, the patient may have other factors that may cause the study to be terminated midway, such as other serious diseases or severe laboratory abnormalities or other family and social factors that will affect the safety of the subjects and the test data as well as the sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Median progression-free survival (mPFS); | — |
Countries
China
Contacts
Public ContactWang Yali
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed