Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer

NCT ID: NCT06241105

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-12-31

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.

Conditions

Recurrent Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lenvatinib+Toripalimab.

Intervention Type: DRUG

Adjustment of Medication Dosage: Throughout the course of treatment, adjustments should be made exclusively to the dosage of the drug Lenvatinib.The starting dosage for lenvatinib is 8 mg, administered orally once a day for a period of four weeks. If no adverse reactions are observed, the dosage can be escalated to 12 mg for individuals weighing over 60 kg. However, if the patient experiences intolerable side effects, the dosage should be decreased back to 8 mg.For individuals weighing less than 60 kg, the maximum dosage is 8 mg per day. Should adverse reactions become intolerable, the dosage may be decreased to 4 mg per day.Withdrawal from the study if still intolerable.

Interventions

Lenvatinib+Toripalimab.

Adjustment of Medication Dosage: Throughout the course of treatment, adjustments should be made exclusively to the dosage of the drug Lenvatinib.The starting dosage for lenvatinib is 8 mg, administered orally once a day for a period of four weeks. If no adverse reactions are observed, the dosage can be escalated to 12 mg for individuals weighing over 60 kg. However, if the patient experiences intolerable side effects, the dosage should be decreased back to 8 mg.For individuals weighing less than 60 kg, the maximum dosage is 8 mg per day. Should adverse reactions become intolerable, the dosage may be decreased to 4 mg per day.Withdrawal from the study if still intolerable.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fengzhi Feng

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhi f Feng, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao Shang, PhD

Role: CONTACT

shang.mm@163.com

13810073050

Zhi f Feng, PhD

Role: CONTACT

fengfz1969@sina.com

Facility Contacts

Xiao Shang, PhD

Role: primary

shang.mm@163.com

13810073050

Zhi f Feng, PhD

Role: backup

fengfz1969@sina.com

Other Identifiers

K3559

Identifier Type: -

Identifier Source: org_study_id