Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Recurrent Ovarian Carcinoma

Treatments: Drug: Lenvatinib+Toripalimab.

Study type: Interventional

Funder types: Other

Identifiers

NCT06241105

K3559

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Lenvatinib+Toripalimab

Experimental group

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.

Treatment:

Drug: Lenvatinib+Toripalimab.