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Platinum-resistant Recurrent Ovarian CancerPhase 2NCT04720807

Letrozole Combined With Anlotinib Hydrochloride in the Treatment of Platinum-resistant Recurrent Ovarian Cancer

A Phase 2 study testing Letrozole combined with anlotinib hydrochloride in people with Platinum-resistant Recurrent Ovarian Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study is a prospective, single-arm, open label, exploratory phase 2 clinical trial, which aims to study the therapeutic effect of letrozole combined with anlotinib hydrochloride in platinum-resistant recurrent ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Letrozole combined with anlotinib hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Sep 2020to 30 Sep 2023
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  • Histologically diagnosed epithelial ovarian cancer (high-grade serous, clear cell, endometrioid ovarian cancer), fallopian tube cancer or primary peritoneal cancer;
  • The patient has undergone surgery and received ≥2 lines of platinum-containing chemotherapy. During the treatment period of the platinum-containing regimen (from the beginning of the treatment to 1 month after the last chemotherapy), the curative effect is non-PD, and the disease relapse/progress within 6 months after the treatment；
  • The patient has measurable lesions with imaging evidence;
  • The expected survival period ≥ 3 months;
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  • Estrogen receptor (ER) is positive in immunohistochemistry of the first or the last surgical specimens;
  • Adequate organ function at screening:
  • 1) Adequate bone marrow function at screening: Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil ≥1.5×109/L; Platelets ≥80×109/L; 2) Biochemical test: Total bilirubin≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT or AST ≤ 5×ULN; Serum creatinine ≤ 1.5×ULN or endogenous creatinine clearance ≥ 50ml/min (Cockcroft-Gault formula); 9. The patient has not been treated with other tyrosine kinase inhibitor (TKI) drugs; 10. The patient has not received tumor endocrine therapy; 11. Patients should have good compliance and the family members agree to cooperate in the survival follow-up.

Who cannot join

  • Patients with other malignant tumors at the same time except for recovery or tumors in a stable state.
  • Pregnant or breast feeding women;
  • Patients participated in other drug clinical trials within six months;
  • Patients with many factors that affect oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
  • Any bleeding event with a severity level of grade ≥ 3 in CTCAE 4.0 in the 4 weeks before screening;
  • Patients with known central nervous system metastasis or a history of the metastasis before screening;
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  • Patients with hypertension who cannot be well controlled by antihypertensive drugs (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg); those with a history of unstable angina; those who are newly diagnosed with angina within 3 months before screening or Myocardial infarction occurred within 6 months before screening; arrhythmia requires long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ II cardiac insufficiency;
  • Long-term unhealed wounds or incomplete fractures;
  • A previous history of organ transplantation;
  • Imaging shows that the tumor has invaded important blood vessels or the researcher has judged that the patient's tumor is highly likely to invade important blood vessels to induce fatal bleeding during treatment;
  • Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L); those with bleeding tendency (INR is normal without using anticoagulants in 14 days before randomization); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; under the condition of INR ≤ 1.5, Low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day) is permitted for preventive purposes;
  • Arteriovenous thrombosis events occurred within one year before screening, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been cured), and pulmonary embolism;
  • Those who have a history of psychotropic drug abuse and can't be prevented or have mental disorders;
  • Have a history of immunodeficiency, or have a history of organ transplantation;
  • According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study;
  • Have a history of surgery within 28 days;
  • A history of abdominal fistula or gastrointestinal perforation within 28 days;
  • People who may receive other systemic anti-tumor treatments or plan to undergo ovarian cancer reduction surgery during the study period.

Trial locations and contacts

1 site in 1 country.

Xipeng Wang, Doctor contact

86-021-25078999

wangxipeng@xinhuamed.com.cn

China1 site, 1 recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

    Xipeng Wang, Doctor, 86-2507-8999, wangxipeng@xinhuamed.com.cn

    Recruiting

Other trials in China

About this study

Official title: Letrozole Combined With Anlotinib Hydrochloride in the Treatment of Platinum-resistant Recurrent Ovarian Cancer: a Prospective, Single-arm, Open Label, Exploratory Phase 2 Clinical Trial.

The study is a prospective, single-arm, open label, exploratory phase 2 clinical trial, which aims to study the therapeutic effect of letrozole combined with anlotinib hydrochloride in platinum-resistant recurrent ovarian cancer.

Read the detailed description

The study is a prospective, single-arm, open label, exploratory phase 2 clinical trial, which aims to study the therapeutic effect of letrozole combined with anlotinib hydrochloride in platinum-resistant recurrent ovarian cancer.The patient has undergone surgery and received ≥2 lines of platinum-containing chemotherapy.

Being tested
Letrozole combined with anlotinib hydrochloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Letrozole combined with anlotinib hydrochlorideDrug

    Letrozole combined with anlotinib hydrochloride in the treatment of platinum-resistant recurrent ovarian cancer.

Study groups in NCT04720807
Study groupRoleWhat they receive
Letrozole combined with anlotinib hydrochlorideExperimentalLetrozole combined with anlotinib hydrochloride in the treatment of platinum-resistant recurrent ovarian cancer.
Receives: Drug: Letrozole combined with anlotinib hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    objective response rate

    Measured: 3 years

Secondary outcomes (3)

  1. PFS

    progression-free survival time

    Measured: 3 years and 5 years

  2. OS

    Overall survival

    Measured: 3 years and 5 years

  3. AE

    Adverse event

    Measured: 3 years and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start1 Sep 2020
  3. Primary completion31 Aug 2022 (estimated)
  4. Study completion30 Sep 2023 (estimated)

Resources

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
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04720807
Sponsor's protocol ID
XH-21-001
Status last verified
Jan 2021
First submitted
14 Jan 2021
Last updated
22 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang Y, Li J, Yang Y, Lu X, Xu H, Zhao S, Guan W, Wang X. Letrozole plus anlotinib as a chemotherapy-free regimen for ER-positive platinum-resistant recurrent epithelial ovarian cancer patients following second-line platinum-based chemotherapy failure: A prospective, single-arm, open-label, phase II study. Gynecol Oncol. 2025 Dec;203:67-74. doi: 10.1016/j.ygyno.2025.10.023. Epub 2025 Oct 29.

    PubMed 41166983

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letrozole combined with anlotinib hydrochloride in people with Platinum-resistant Recurrent Ovarian Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 9 inclusion and 18 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 22 Jan 2021. 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 Xipeng Wang, Doctor (86-021-25078999, wangxipeng@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 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 NCT04720807, 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 22 Jan 2021.

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