Trials / Unknown
UnknownNCT04983550
Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC
A Multicenter, Randomized, Controlled, Open-label, Phase II Study to Evaluate the Efficacy and Safety of SG001 in Combination With PLD in Patients With Platinum-resistant Relapsed Epithelial Ovarian Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multicenter, randomized, controlled, open-label, phase II study to evaluate the efficacy and safety of SG001 in combination with doxorubicin hydrochloride liposome injection in patients with platinum-resistant relapsed epithelial ovarian cancer.
Detailed description
This is a multicenter, randomized, controlled, open-label, phase II clinical study to evaluate the efficacy and safety of SG001 in combination with doxorubicin hydrochloride liposome injection in patients with platinum-resistant relapsed intermediate to advanced epithelial ovarian cancer, and to provide a basis for recommending the SG001 combination dosing regimen for subsequent studies. This study will enroll patients with histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, FIGO stage II-IV, platinum-resistant relapse (defined as disease progression within 6 months after the last platinum-containing chemotherapy) and non-platinum refractory (defined as disease progression within 4 weeks after the first platinum-containing chemotherapy) with up to three prior lines of platinum-containing systemic chemotherapy, up to two lines of platinum-free systemic chemotherapy, and at least one measurable tumor lesion (according to RECIST 1.1).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SG001 | Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg q2w |
| DRUG | Doxorubicin hydrochloride liposome injection | Doxorubicin hydrochloride liposome injection 40mg/m \^2 q4w |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2023-01-01
- Completion
- 2024-01-01
- First posted
- 2021-07-30
- Last updated
- 2021-07-30
Source: ClinicalTrials.gov record NCT04983550. Inclusion in this directory is not an endorsement.