Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer

Phase 2

Recruiting

• Conditions: Recurrent Ovarian Carcinoma
• Interventions: Drug: Lenvatinib+Toripalimab.

• Registration Number: NCT06241105
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2024-01-09
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lenvatinib+Toripalimab	Lenvatinib+Toripalimab.	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.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	From the start of treatment to a minimum of 3 years	This term denotes the duration from the initiation of enrollment to the point of neoplasm progression or death.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From the start of treatment to a minimum of 3 years	Overall Survival refers to the duration from the initiation of enrollment until death, regardless of the cause.For participants who have not succumbed, the data will be censored at the most recent date known for their survival.
Objective Response Rate (ORR)	From the start of treatment to a minimum of 3 years	The Objective Response Rate (ORR) is defined as the sum of the proportions of complete and partial responses. This is achieved when there is a reduction in the neoplasm volume to a predetermined value, coupled with a decrease in serum CA 125 concentration by more than 50% post-treatment compared to pre-treatment levels, sustained for a minimum duration of 4 weeks.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China