Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to validate the efficacy and safety of anti-PD-1 in combination with neoadjuvant chemotherapy in women with advanced ovarian cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIC | Experimental |
|
|
| NC | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-A317 | Drug | PD-1 antibody,Tislelizumab (BGB-A317) |
| |
| albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | 12 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| R0 rate | R0 rate of IDS(interval debulking surgery) after neoadjuvant chemotherapy(after the completion of 3rd cycle) | after interval debulking surgery for one week |
| CRR | CRR is defined as the percentage of the participants in the ITT population who have a Complete Response or Partial Response. The CRR will be assessed by a blind independent central reviewer per RECIST 1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhigang Zhang, MD | Contact | +86057189713631 | zzg2011@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianwei Zhou, MD | Second Affiliated Hospital of Zhejiang University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39909529 | Derived | Zhu Y, Fei J, Zhu X, Zhang J, Zhou J, Zhang Z. Efficacy and safety of NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr (NAIVE study) in China: study protocol of an open-label, phase II, randomised controlled trial. BMJ Open. 2025 Feb 5;15(2):e092545. doi: 10.1136/bmjopen-2024-092545. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 |
|
| 3 months |
| PRR | At interval cytoreduction pathologic complete remission rate will be measured using RECIST and immune-related response criteria. | 3 months |
| OS | OS is defined as the time from the date of randomization until death. | 5 years |
| AEs | Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy | 3 months |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |