Clinical trial NCT06241105: Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer
Official title: A Prospective Phase II Clinical Trial of Lenvatinib in Combination With Toripalimab for Patients With Platinum-Resistant Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Ovarian Carcinoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Dalian Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2024-02-05
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Lenvatinib plus Toripalimab
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From the start of treatment to a minimum of 3 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the start of treatment to a minimum of 3 years
measure: Objective Response Rate (ORR)
timeFrame: From the start of treatment to a minimum of 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhi f Feng, PhD
role: PRINCIPAL_INVESTIGATOR
References: