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
This study is a single-arm, open-label, exploratory clinical study, the main purpose is to evaluate the combination of envafolimab, lenvatinib VP-16 in the treatment of platinum-resistant recurrent epithelial ovarian cancer,primary fallopian tube cancer and primary peritoneal carcinoma.
Platinum-resistant patients who have received at least 1 line chemotherapy in the past and the recurrence time is less than 6 months will receive envafolimab combined with lenvatinib and VP-16 for 6 cycles, followed by single-agent envafolimab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| envafolimab,lenvatinib,VP-16 | Experimental | envafolimab:400mg,sc,d1,Q3W; lenvatinib:8 mg(BW<60 kg) OR 12 mg(BW≥60 kg),po,qd,d1-21,Q3W; VP-16:50 mg/d, po,d1-14,Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envafolimab | Drug | 400mg,sc,d1,Q3W |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | 12 months |
| PFS | progression free survival | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Shen, MD | Contact | 025-83262742 | shenyang0924@sina.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yang Shen, MD | Zhongda Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40658469 | Derived | Ding B, Yu T, Zheng S, Xu J, Ji F, Lin H, Zhao X, Qiu S, Shen Y. Combination therapy for platinum-resistant ovarian cancer: a novel at-home regimen with envafolimab, lenvatinib, and etoposide. Oncologist. 2025 Sep 1;30(9):oyaf210. doi: 10.1093/oncolo/oyaf210. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718749 | envafolimab |
| D007167 | Immunotherapy |
| C531958 | lenvatinib |
| D000092004 | Tyrosine Kinase Inhibitors |
| D005047 | Etoposide |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D047428 | Protein Kinase Inhibitors |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lenvatinib | Drug | 8 mg(BW<60 kg) OR 12 mg(BW≥60 kg),po,qd,d1-21,Q3W |
|
|
| VP-16 | Drug | 50 mg/d, po,d1-14,Q3W |
|
|
| DCR |
disease control rate |
| 9 months |
| AEs AEs | a advers adverse events | 12 months |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| 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 |
| D004791 |
| Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |