Recurrent Ovarian CarcinomaPhase 2NCT06241105
Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer
A Phase 2 study testing Lenvatinib+Toripalimab. in people with Recurrent Ovarian Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent Ovarian Carcinoma
- What is being tested?
- Lenvatinib+Toripalimab.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 75 years;
- Platinum-resistant recurrence of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
- According to the RECIST 1.1 criteria, there should be at least one measurable lesion or a CA 125 level of ≥ 70 IU/L.
- ECOG 0-2；
- 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.
- 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.
- Those who are expected to survive longer than 3 months. Patients were unconscious and volunteered to participate in the study.
Who cannot join
- Uncontrollable malignant hypertension;
- Imaging showed that the tumor invaded important blood vessels;
- Contraindications to the use of antiangiogenic agents;
- Contraindications to checkpoint inhibitors;
- Patients presenting with abdominal fistula, gastrointestinal perforation, and pelvic-abdominal abscess;
- Simultaneous involvement or engagement in another clinical trial within a one-month period that could potentially influence the outcomes of this study.
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- Known hypersensitivity to study-related drugs or their excipients;
- Individuals with severe heart, liver, kidney, and other serious concurrent diseases that may pose a threat to life;
- Patients judged by the investigator to be inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country.
Zhi f Feng, PhD contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiao Shang, PhD, 13810073050, shang.mm@163.com
Zhi f Feng, PhD, fengfz1969@sina.com
About this study
Official title: 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.
- Conditions
- Recurrent Ovarian Carcinoma
- Being tested
- Lenvatinib+Toripalimab.
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib+Toripalimab | Experimental | 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. Receives: Drug: Lenvatinib+Toripalimab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
This term denotes the duration from the initiation of enrollment to the point of neoplasm progression or death.
Measured: From the start of treatment to a minimum of 3 years
Secondary outcomes (2)
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.
Measured: From the start of treatment to a minimum of 3 years
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.
Measured: From the start of treatment to a minimum of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lenvatinib plus Toripalimab
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Dalian Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Responsible party
- Principal investigator, Fengzhi Feng, Peking Union Medical College Hospital
- Investigators
- Zhi f Feng, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241105
- Sponsor's protocol ID
- K3559
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40616958
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Trial of Lenvatinib in Combination With Toripalimab for Patients With Platinum-Resistant Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06241105
- Acronym / sponsor ID
- K3559
- Conditions
- Recurrent Ovarian Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Dalian Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lenvatinib plus Toripalimab
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib+Toripalimab | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 to 75 years;
- Platinum-resistant recurrence of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
- According to the RECIST 1.1 criteria, there should be at least one measurable lesion or a CA 125 level of ≥ 70 IU/L.
- ECOG 0-2；
- 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.
Key exclusion criteria (9 listed)
- Uncontrollable malignant hypertension;
- Imaging showed that the tumor invaded important blood vessels;
- Contraindications to the use of antiangiogenic agents;
- Contraindications to checkpoint inhibitors;
- Patients presenting with abdominal fistula, gastrointestinal perforation, and pelvic-abdominal abscess;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Lenvatinib+Toripalimab |
Primary outcome
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.
2 secondary outcomes
Overall Survival (OS)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 40616958Su 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi f Feng, PhD contact
Zhi f Feng, PhD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib+Toripalimab. in people with Recurrent Ovarian Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Shang, PhD (13810073050, shang.mm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the start of treatment to a minimum of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06241105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.