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Platinum Resistant Ovarian CancerPhase 2NCT07117877

Etoposide Capsules Combined With Bevacizumab and Iparomlimab and Tuvonralimab in the Treatment of Platinum Resistant or Platinum Refractory Ovarian Cancer

A Phase 2 study testing Etoposide Capsules, Bevacizumab and Iparomlimab and Tuvonralimab (QL1706) in people with Platinum Resistant Ovarian Cancer and Platinum Refractory Epithelial Ovarian Cancer, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking Etoposide Capsules combined With Bevacizumab and Iparomlimab and Tuvonralimab is safe and works well for people with platinum-resistant or platinum refractory ovarian cancer . Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Etoposide Capsules, Bevacizumab and Iparomlimab and Tuvonralimab (QL1706)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
15 Sep 2025to 31 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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: 18-75, female;
  • According to RECIST 1.1 criteria, there are measurable lesions at baseline;
  • ECOG PS： 0-1；
  • Epithelial ovarian, fallopian tube, and primary peritoneal cancer with platinum resistance or platinum refractory recurrence; Provide 10 white films for pathological type confirmation and efficacy marker exploration, and meet all of the following conditions.
  • ① Received systemic treatment with ≥ 1 line and ≤ 6 lines, among which only received systemic treatment with ≤ 4 lines after platinum resistance relapse.
  • ② Previous treatments should include at least one platinum based chemotherapy regimen. There are two specific situations:
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  • For patients who have only received 1-line platinum based chemotherapy in the past, disease remission (CR or PR) must be achieved, and disease progression must occur within a period of ≥ 4 weeks and<6 months after the last platinum based chemotherapy.
  • For patients who have received systemic treatment from line 2 to line 5 in the past, it is required that disease progression must occur within a period of less than 6 months after the last platinum based chemotherapy.
  • Note: When determining the number of lines, the following requirements should be noted:
  • The overall count of neoadjuvant ± adjuvant systemic therapy is one line. Maintenance treatment does not calculate the number of lines separately. Simple endocrine therapy is counted as a baseline, but the use of endocrine therapy due to non disease progression (such as only elevated CA-125) is not counted as a baseline.
  • Changing the treatment plan due to intolerance without disease progression is not considered as changing the line.
  • The subject needs to experience disease progression after the final systemic treatment.
  • The main organ functions well and meets the following criteria:
  • Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L;
  • Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for tumor liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome subjects, ≤ 3 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 60mL/min;
  • Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;
  • Urine routine examination shows urinary protein<2+; If urinary protein is ≥ 2+, 24-hour urinary protein quantification should be<1 g;
  • Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ 50%.
  • Non surgical sterilization or female patients of childbearing age are required to use two medically approved contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum HCG test within 72 hours before their first medication and must be non lactating; For male patients whose partners are women of childbearing age, two effective methods of contraception should be used during the study treatment period and within 3 months after the end of the study treatment period.
  • The subjects voluntarily joined this study, signed informed consent forms, had good compliance, and cooperated with follow-up.

Who cannot join

  • Patients who participate in other clinical trials simultaneously;
  • Allergic constitution, including a history of severe drug allergies or drug allergic reactions; Known to be allergic or intolerant to the investigational drug;
  • No measurable lesions or lesions that cannot be evaluated;
  • Patients with untreated central nervous system metastases, who have previously received systemic or curative treatment for brain or meningeal metastases (radiotherapy or surgery), have been confirmed stable for at least one month by imaging, and have stopped systemic hormone therapy (dose>10mg/day prednisone or other therapeutic hormones) for more than two weeks without clinical symptoms can be included;
  • Those who are unable to swallow pills normally or have gastrointestinal dysfunction, as determined by researchers, may affect drug absorption;
  • Individuals who have experienced intestinal obstruction within the past 3 months;
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  • At present, there are uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as those that cannot be effectively controlled by diuretics or puncture methods as determined by researchers);
  • Suffering from uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; Known history of HIV infection or AIDS; Active syphilis; Active tuberculosis; Active infection; Uncontrolled hypertension and symptomatic heart failure; Active bleeding;
  • History of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or other malignant tumors within 5 years prior to the initial administration of the study (excluding completely relieved carcinoma in situ and malignant tumors with slow progression determined by the investigator)
  • Other incurable malignant tumors in the past (within 5 years) or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer with no recurrence after radical surgery>3 years;
  • Pregnant or lactating women;
  • According to the researchers' assessment, there may be other factors that could lead to the forced termination of this study, such as other serious illnesses (including mental illnesses) requiring concurrent treatment, serious laboratory abnormalities, and family or social factors that could affect the safety of the subjects or the collection of data and samples.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xingzhu Ju, PhD contact

021-64175590

lizfeng1231@163.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xingzhu Ju, PhD, 021-64175590, lizfeng1231@163.com

Other trials in China

About this study

Official title: Etoposide Capsules Combined With Bevacizumab and Iparomlimab and Tuvonralimab in the Treatment of Platinum Resistant or Platinum Refractory Ovarian Cancer: a Single Arm, Open, Single Center, Phase II Clinical Study

This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking Etoposide Capsules combined With Bevacizumab and Iparomlimab and Tuvonralimab is safe and works well for people with platinum-resistant or platinum refractory ovarian cancer . Researchers will look at the Progression-Free Survival, Objective Response Rate, Overall Survival, safety, and any side effects.

Being tested
Etoposide Capsules, Bevacizumab, Iparomlimab and Tuvonralimab (QL1706)
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • Etoposide CapsulesDrug

    50 mg(25mg/pill, 2 pills at a time) orally, qd, days 1 to 14, per cycle

  • BevacizumabDrug

    7.5mg/kg, i.v, q3w

  • Iparomlimab and Tuvonralimab (QL1706)Drug

    5mg/kg, i.v., q3w

Study groups in NCT07117877
Study groupRoleWhat they receive
Etoposide+Bevacizumab+Iparomlimab and TuvonralimabExperimentalParticipants will receive Etoposide Capsules, Bevacizumab and Iparomlimab and Tuvonralimab in combination. 21 days as a cycle.
Receives: Drug: Etoposide Capsules; Drug: Bevacizumab; Drug: Iparomlimab and Tuvonralimab (QL1706)

What is being measured

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

  1. PFS

    Progression-free survival, according to RECIST v1.1

    Measured: approximately 2 years

Secondary outcomes (3)

  1. ORR

    Objective response rate, according to RECIST v1.1

    Measured: Up to 24 months

  2. OS

    Overall survival, according to RECIST v1.1

    Measured: Up to 2 years

  3. AEs

    Adverse Events, according to CTCAE V5.0 criteria, During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event.

    Measured: From the first drug administration to within 30 days for the last treatment dose

Timeline

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

  1. First posted12 Aug 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2027 (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
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07117877
Sponsor's protocol ID
OCR-EBQ-2025
Status last verified
Aug 2025
First submitted
5 Aug 2025
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data is available per require after approved by ethics broad

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etoposide Capsules, Bevacizumab and Iparomlimab and Tuvonralimab (QL1706) in people with Platinum Resistant Ovarian Cancer and Platinum Refractory Epithelial Ovarian Cancer, run by Fudan University 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 20 inclusion and 12 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: opening soon, as of the sponsor's last update on 28 Aug 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xingzhu Ju, PhD (021-64175590, lizfeng1231@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: approximately 2 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 NCT07117877.

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 28 Aug 2025.

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