Clinical trial · Interventional
Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer
An Open, Single-arm Clinical Study of Envafolimab, Lenvatinib Combined With VP-16 in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer,Primary Fallopian Tube Cancer and Primary Peritoneal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer, Epithelial | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Envafolimab | Drug | — | UNRESOLVED |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| VP-16 | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- envafolimab,lenvatinib,VP-16
- description
- 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
- interventionNames
- Drug: Envafolimab
- Drug: Lenvatinib
- Drug: VP-16
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 6 months
- description
- objective response rate
Secondary outcomes (4)
- measure
- OS
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years; * ECOG 0-1 * Life expectancy of at least 3 months; * Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer; Ovarian cancer patients with drug-resistant recurrence after platinum-based chemotherapy; * At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm(according to RECIST 1.1); * Satisfactory main organ function,laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count(ANC) ≥1.5×109/L, platelet count(PLT) ≥80×109/L, Serum creatinine(CR)≤1.5 upper normal limitation (UNL),total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; * Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects; Exclusion Criteria: * Suffered from other malignant tumors within 5 years before the start of treatment in this study; * Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group; * Subjects with any severe and/or uncontrolled disease ; * Poorly controlled diabetes (fasting blood glucose \[FBG\] \> 10 mmol/L) ; * Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture; * Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ; * Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ; * Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ; * Allergic to the active ingredients or excipients of the study drug ; * Unsuitable for the study or other chemotherapy determined by investigator.
References
Publications (1)
- DERIVEDDing 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. PMID 40658469