Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer

February 2, 2024 updated by: Fengzhi Feng, Peking Union Medical College Hospital

A Prospective Phase II Clinical Trial of Lenvatinib in Combination With Toripalimab for Patients With Platinum-Resistant Recurrent Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 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.
From the start of treatment to a minimum of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 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.
From the start of treatment to a minimum of 3 years
Objective Response Rate (ORR)
Time Frame: 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.
From the start of treatment to a minimum of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The Second Affiliated Hospital of Dalian Medical University

Investigators

  • Principal Investigator: Zhi f Feng, PhD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K3559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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