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New hope for hard-to-treat ovarian cancer: experimental combo enters phase 2 trial

NCT ID NCT06434610

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the experimental drug B013 to standard chemotherapy (paclitaxel) can help people with ovarian, fallopian tube, or primary peritoneal cancer that has stopped responding to platinum-based treatments. About 90 participants will receive either the combination or a placebo plus chemotherapy. The main goal is to see if the combination delays cancer growth or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects who voluntarily participate in this study and sign informed consent form; 2. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence; 3. ECOG performance status of 0 or 1; 4. Expected survival \> 12 weeks; 5. The subject has at least one measurable lesion; 6. Normal function of major organs; 7. The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose. Exclusion Criteria: 1. Subjects who have received prescribed treatment previously; 2. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent; 3. Subjects with known central nervous system metastasis and multiple bone metastasis; 4. Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks; 5. Have a history of other malignant tumors within 5 years before signing the informed consent; 6. Subjects with prescribed cardiovascular diseases; 7. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization; 8. Had severe lung disease before randomization; 9. Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \> grade 2, and other reversible toxicity was \> grade 1; 10. Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery; 11. Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs; 12. Subjects who are known to be allergic to any component of B013 or paclitaxel. 13. Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders; 14. Female subjects who are pregnant or breastfeeding; 15. Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, China

  • Cancer Hospital of Shandong First Medical University

    RECRUITING

    Jinan, China

  • Fudan University Shanghai Cancer center

    RECRUITING

    Shanghai, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, China

  • Shananxi Provincial Cancer Hospital

    RECRUITING

    Xi'an, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Bengbu Medical University

    RECRUITING

    Bengbu, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, China

  • The Obstetrics & Gynecology Hospital of Fudan University

    RECRUITING

    Shanghai, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, China

  • XiangYa Hospital CentralSouth University

    RECRUITING

    Changsha, China

  • Yibin city second people's Hospital

    RECRUITING

    Yibin, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.