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
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
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 →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.
Exclusion Criteria:
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
400mg,sc,d1,Q3W
Also known as: Immunotherapy
8 mg(BW\<60 kg) OR 12 mg(BW≥60 kg),po,qd,d1-21,Q3W
Also known as: Tyrosine kinase inhibitors
50 mg/d, po,d1-14,Q3W
Also known as: Chemotherapy
ORR
objective response rate
Time frame: 6 months
OS
overall survival
Time frame: 12 months
PFS
progression free survival
Time frame: 12 months
DCR
disease control rate
Time frame: 9 months
AEs AEs
a advers adverse events
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
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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Zhongda Hospital