Cervical Carcinoma Clinical Trial
Official title:
A Phase I/II Study to Evaluate Safety and Pharmacokinetics and Initial Efficacy of ZG005 in Combination With Paclitaxel Plus Cisplatin/Carboplatin ± Bevacizumab in Patients With Advanced Cervical Carcinoma
This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | May 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Fully understand the study and voluntarily sign the informed consent form. - Female 18-70 years of age; - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or - Life expectancy = 3 months. Exclusion Criteria: - Patients were deemed unsuitable for participating in the study by the investigator for any reasons. |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Cancer Hospital | Zhejiang | Hangzhou |
Lead Sponsor | Collaborator |
---|---|
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose Limiting Toxicity (DLT) | Up to 2 years | ||
Primary | Objective Response Rate (ORR) | ORR was defined as the percentage of the participants in the analysis population who have a Complete Response or a Partial Response. The ORR per RECIST 1.1 as assessed by Investigator is presented. | Up to 2 years |
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