CClinicalTrials.gg
Status unknownNCT05422183Updated Jun 16, 2022

Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer

A Phase 2 interventional study of Envafolimab and Lenvatinib in Ovarian Cancer, Epithelial, sponsored by Zhongda Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by Zhongda Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Ovarian Cancer, Epithelial
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Zhongda Hospital is the lead sponsor of 101 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    envafolimab,lenvatinib,VP-16

    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

    Drug: Envafolimab · Drug: Lenvatinib · Drug: VP-16

Interventions

  • DrugEnvafolimab

    400mg,sc,d1,Q3W

    Also known as: Immunotherapy

  • DrugLenvatinib

    8 mg(BW\<60 kg) OR 12 mg(BW≥60 kg),po,qd,d1-21,Q3W

    Also known as: Tyrosine kinase inhibitors

  • DrugVP-16

    50 mg/d, po,d1-14,Q3W

    Also known as: Chemotherapy

06

What researchers measure

Primary outcomes

  1. ORR

    objective response rate

    Time frame: 6 months

Secondary outcomes

  1. OS

    overall survival

    Time frame: 12 months

  2. PFS

    progression free survival

    Time frame: 12 months

  3. DCR

    disease control rate

    Time frame: 9 months

  4. AEs AEs

    a advers adverse events

    Time frame: 12 months

07

Study locations

1 site
  • Zhongda Hospital
    Nanjing, Jiangsu 210000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05422183
Lead sponsor
Zhongda Hospital
Responsible party
Yang Shen (chief physician, Zhongda Hospital) — Principal investigator
First posted
Jun 16, 2022
Start date
Jun 30, 2022 (estimated)
Primary completion
Dec 30, 2022 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Jun 16, 2022

Study contacts

Yang Shen, MD
Contact
shenyang0924@sina.cn
025-83262742
Yang Shen, MD
study director · Zhongda Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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