Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer

Recurrent Ovarian Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241105
• Other study ID #: K3559
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Peking Union Medical College Hospital
• Contact: Xiao Shang, PhD
• Phone: 13810073050
• Email: shang.mm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Recurrent Ovarian Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	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	Overall Survival (OS)	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
Secondary	Objective Response Rate (ORR)	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