Double-Target immunotherapy added to standard care for aggressive cervical cancer

NCT ID NCT06714084

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether adding cadonilimab, an immunotherapy drug, to chemotherapy before and after standard chemoradiation can help women with high-risk, locally advanced cervical cancer. The trial enrolls 20 women who have not received prior treatment. Participants receive two cycles of cadonilimab plus chemotherapy, then standard chemoradiation, followed by up to one year of cadonilimab alone. The study measures how many patients remain progression-free at 12 months and how many respond to the initial treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cadonilimab, an experimental immunotherapy drug that targets PD-1 and CTLA-4
What this could lead to
If it works, this could offer a new treatment option that combines immunotherapy with standard chemotherapy and radiation for high-risk cervical cancer.
What could go wrong
The trial is very small, with only 20 participants, and it is not randomized, so results may not be reliable. Immunotherapy can cause serious side effects, and it is too early to know if this approach helps patients live longer.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

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

Started

Oct 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Written informed consent must be provided and recorded at the trial site before any trial procedure is initiated; 2. Female patients aged ≥ 18 years and \< 75 years; 3. Histologically confirmed diagnosis of cervical malignancy, and the histological type include squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, and other histological types; 4. Have not received systematic or local anti-tumor treatment for cervical cancer before the first medication, including but not limited to radiotherapy, chemotherapy, immunotherapy, biologics, small molecule targeted therapy, etc; 5. Patients who agree to receive radical synchronous radiotherapy and chemotherapy, and whose researchers have determined that there are no absolute contraindications to radiotherapy and chemotherapy; 6. High risk cervical cancer patients, including those with local cervical tumors\>5cm, lymph node metastasis or stage IV patients; 7. The subjects agree to collect tumor tissue and peripheral blood samples required during the screening period and research process, and apply them to relevant studies; 8. Has good organ function; 9. No history of using immune checkpoint inhibitors; 10. Female subjects with fertility must undergo a urine or serum pregnancy test (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test must be performed, based on the serum pregnancy result) within 3 days before the first use of medication, and the result must be negative. If a female subject with fertility has sexual intercourse with an unsterilized male partner, the subject must self screen and adopt an acceptable contraceptive method, and must agree to continue using the contraceptive method for 120 days after the last use of the study drug; Whether to stop contraception after this point in time should be discussed with the researchers. Periodic abstinence and safe period contraception are unacceptable contraceptive methods; 11. Women with fertility refer to those who have not undergone surgical sterilization (i.e. bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or have not reached menopause (menopause is defined as a period of at least 12 consecutive months without alternative medical reasons, and serum follicle stimulating hormone levels are within the laboratory reference range for postmenopausal women); 12. Efficient contraceptive methods refer to contraceptive methods with a low failure rate (such as less than 1% per year) when used consistently and correctly. Not all contraceptive methods are efficient. In addition to barrier contraception, female subjects with fertility must also use hormone contraception alone (such as birth control pills) to ensure that pregnancy does not occur 13. ECOG score ≤ 1; 14. Expected survival period\>12 weeks; 15. Understand the experimental process and have the ability to comply with the experimental protocol during the duration of the experiment, including cooperating with any treatments, examinations, tests, follow-up, and survey questionnaires required to complete the experiment; 16. The patient is willing to cooperate in completing the quality of life questionnaire survey during the trial treatment and follow-up process, and agrees that the results of these questionnaire surveys will be used for clinical research; - Exclusion Criteria:1. Personnel involved in the development or implementation of research plans; 2. Previously received PD-1/PD-L1 and CTLA-4 bispecific antibody therapy or drugs that synergistically inhibit T cell receptors (such as OX-40, CD137); 3. Individuals who are known to be allergic to the active ingredients or excipients of the investigational drug Cardenimumab; 4. Symptomatic or uncontrolled brain metastases that require simultaneous treatment, including but not limited to surgery, radiation, and/or corticosteroids, or clinical manifestations of spinal cord compression; 5. Currently participating in interventional clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration; 6. Diagnosed with other malignant diseases other than cervical cancer within 5 years before the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone curative resection); 7. Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments; Note: Patients with cataracts, Graves' disease, or psoriasis who do not require systematic treatment (within the past 2 years) are not excluded; 8. Within 3 months prior to the first administration, there is active hemoptysis (at least 2.5ml or 1/2 teaspoon of blood is expelled at a time); 9. Receive a live vaccine within one month before the first administration; 10. Note: It is allowed to receive inactivated vaccine for seasonal influenza within 30 days before the first administration; However, intranasal administration of attenuated live influenza vaccine is not allowed. 11\. Received platelet or red blood cell transfusion within 4 weeks before the first administration; 12. Have undergone major surgical treatment within 4 weeks prior to the first administration (excluding surgery for biopsy purposes) or are expected to undergo major surgery during the study period; 13. Within 2 weeks before the first administration, he has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion); 14. Within 7 days prior to the first administration, the individual is receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs); 15. Note: Physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent) are allowed to be used; 16. Undertook minor surgeries (outpatient/inpatient surgeries requiring local anesthesia, including central venous catheterization) within 48 hours prior to the initial receipt of the study drug; 17. Patients with clinically uncontrollable pleural/peritoneal effusion (those who do not require drainage or have no significant increase in effusion after stopping drainage for 3 days can be enrolled); 18. Severe unhealed wounds, ulcers, or fractures; 19. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 20. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 21. Active hepatitis B without treatment; 22. Women who are pregnant or breastfeeding, or planning to become pregnant during the study treatment period; 23. There are unresolved previous treatment toxicities in clinical practice (≥ grade 2, excluding hair loss, neuralgia, lymphopenia, and depigmentation of the skin); 24. The presence of any serious or uncontrollable systemic disease; 25. Medical history or disease evidence that may interfere with the trial results, hinder the full participation of the subjects in the study, abnormal treatment or laboratory test values, or other situations that the researchers consider unsuitable for inclusion. The researchers believe that there are other potential risks that are not suitable for participation in this study. \-

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Conditions

The condition(s) this trial relates to.

cervical cancer Uterine Cervical Neoplasms

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

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

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