Clinical trial · Interventional
Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer
A Prospective Phase II Clinical Trial of Lenvatinib in Combination With Toripalimab for Patients With Platinum-Resistant Recurrent Ovarian Cancer
- 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)
The investigators propose to initiate a study assessing the efficacy and safety of a lower initial dosage of lenvatinib combined with toripalimab in patients suffering from platinum-resistant recurrent ovarian cancer. The objective of this research is to offer a novel therapeutic approach for patients battling relapsed ovarian cancer with platinum resistance.
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 |
|---|---|---|---|
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib+Toripalimab. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenvatinib+Toripalimab
- description
- 1. Administer 8 mg of Lenvatinib orally, once a day, for continuous usage; 2. Administer 240mg of Toripalimab via intravenous infusion, first time seven days post-lenvatinib intake, and subsequently every three weeks thereafter.
- interventionNames
- Drug: Lenvatinib+Toripalimab.
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From the start of treatment to a minimum of 3 years
- description
- This term denotes the duration from the initiation of enrollment to the point of neoplasm progression or death.
Secondary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18 to 75 years; 2. Platinum-resistant recurrence of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. 3. According to the RECIST 1.1 criteria, there should be at least one measurable lesion or a CA 125 level of ≥ 70 IU/L. 4. ECOG 0-2; 5. Liver and Kidney Function: Serum creatinine levels should be ≤ 1.5 times the upper limit of the normal range.AST and ALT levels should be ≤ 2.5 times the upper limit of normal, or ≤ 5 times the upper limit of normal if liver metastases are present;total bilirubin should be ≤ 1.5 times the upper limit of the normal range. 6. Participants of reproductive age must consent to the use of effective contraceptive methods throughout the duration of the study.Women of reproductive age must yield a negative result in serum or urine pregnancy tests.Non-lactating patients. 7. Those who are expected to survive longer than 3 months. Patients were unconscious and volunteered to participate in the study. Exclusion Criteria: 1. Uncontrollable malignant hypertension; 2. Imaging showed that the tumor invaded important blood vessels; 3. Contraindications to the use of antiangiogenic agents; 4. Contraindications to checkpoint inhibitors; 5. Patients presenting with abdominal fistula, gastrointestinal perforation, and pelvic-abdominal abscess; 6. Simultaneous involvement or engagement in another clinical trial within a one-month period that could potentially influence the outcomes of this study. 7. Known hypersensitivity to study-related drugs or their excipients; 8. Individuals with severe heart, liver, kidney, and other serious concurrent diseases that may pose a threat to life; 9. Patients judged by the investigator to be inappropriate for participation in the study.
References
Publications (1)
- DERIVEDSu H, Shang X, Liu H, Tian M, Yu Y, Xu Y, Jiang K, Feng F. Low-dose lenvatinib plus toripalimab for patients with platinum-resistant recurrent ovarian cancer: preliminary results from a multicenter, phase II trial (NCT06241105). Gynecol Oncol. 2025 Aug;199:124-132. doi: 10.1016/j.ygyno.2025.06.023. Epub 2025 Jul 4. PMID 40616958