Recurrent Ovarian Carcinoma
Conditions
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.
Interventions
DRUGLenvatinib+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.
Sponsors
The Second Affiliated Hospital of Dalian Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Lenvatinib plus Toripalimab
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Objective Response Rate (ORR) | 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. |
Countries
China
Contacts
Primary ContactXiao Shang, PhD
Backup ContactZhi f Feng, PhD
Outcome results
None listed