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| Name | Class |
|---|---|
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib+Toripalimab | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib+Toripalimab. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Shang, PhD | Contact | 13810073050 | shang.mm@163.com | |
| Zhi f Feng, PhD | Contact | fengfz1969@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi f Feng, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40616958 | Derived | Su H, Shang X, Liu H, Tian M, Yu Y, Xu Y, Jiang K, Feng F. Low-dose lenvatinib plus toripalimab for patients with platinum-resistant recurrent ovarian cancer: preliminary results from a multicenter, phase II trial (NCT06241105). Gynecol Oncol. 2025 Aug;199:124-132. doi: 10.1016/j.ygyno.2025.06.023. Epub 2025 Jul 4. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Lenvatinib plus Toripalimab
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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 |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |