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New combo therapy aims to boost survival in advanced cervical cancer

NCT ID NCT06416696

What the study statuses mean

This study's is highlighted.

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase II trial is testing whether adding the immunotherapy drug toripalimab to standard chemoradiotherapy can improve outcomes for patients with high-risk locally advanced cervical cancer. About 57 participants will receive the combination, followed by maintenance toripalimab. The main goal is to see if this approach increases the two-year survival rate without the cancer progressing.

What this could mean

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

Active substance
Toripalimab (a PD-1 inhibitor) combined with cisplatin chemotherapy and radiation therapy
What this could lead to
If successful, this could offer a more effective treatment option for high-risk cervical cancer patients, potentially improving survival rates and making therapy more accessible.
What could go wrong
This is a small, early-phase (phase II) study with only 57 participants, so results may not apply to everyone. Side effects from the drug combination are possible, and the trial is not yet complete.

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 57 people

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

Started

Jan 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 70 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. Patients with histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 2. FIGO 2018 staging criteria classifying the disease as stages III-IVA. 3. Age range from 18 to 70 years inclusive. 4. No prior receipt of surgery, radiotherapy, or systemic anticancer therapy for the treatment of cervical cancer. 5. No previous exposure to the study drug. 6. Presence of at least one measurable or evaluable lesion as per RECIST version 1.1, with the measurable lesion exhibiting a longest diameter of ≥10 mm on spiral CT scan or a shortest diameter of ≥15 mm for enlarged lymph nodes, which has not been previously irradiated. 7. Absence of central nervous system diseases, both primary and metastatic. 8. WHO/ECOG performance status score of 0-1. 9. Anticipated survival duration of at least 12 weeks. 10. Adequate organ function within the following parameters (without the use of any blood components, cytokines, or growth factors within 14 days prior to randomization): 1. Absolute neutrophil count (ANC) ≥1.5×10\^9/L 2. Platelet count ≥90×10\^9/L 3. Hemoglobin level ≥90 g/L 4. Serum albumin level ≥30 g/L 5. Bilirubin level ≤1.5 times the upper limit of normal (ULN) 6. Alanine transaminase (ALT) and aspartate transaminase (AST) levels ≤3×ULN 7. Serum creatinine level ≤1.5×ULN 8. Thyroid-stimulating hormone (TSH) level ≤1×ULN (with eligibility also extended to patients with free triiodothyronine \[FT3\] or free thyroxine \[FT4\] levels ≤1×ULN). 11. For women of childbearing potential not undergoing surgical sterilization, a negative serum pregnancy test (hCG) within 72 hours prior to study randomization is required; breastfeeding must be absent. Additionally, the use of a medically approved contraceptive method is mandatory from the time of informed consent through the study treatment period and for 120 days following the final administration of the trial medication or 180 days after the last chemotherapy/radiotherapy session. Participants must also agree not to donate eggs for reproductive purposes or to freeze/preserve eggs for this use during the aforementioned period. 12. Provision of a tumor tissue biopsy specimen is mandatory. 13. Informed consent must be obtained with documentation. 14. Availability for follow-up assessments. Exclusion Criteria: * 1\. Known hypersensitivity to any component of the study medication. 2. Participation in other clinical trials, with a washout period of less than 4 weeks following completion. 3\. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 monoclonal antibodies. 4\. Patients requiring immunosuppressive pharmacotherapy. 5. Individuals requiring systemic or absorbable topical corticosteroids at immunosuppressive doses. Use of prednisone at a dosage greater than 10mg/day or equivalent is prohibited within two weeks of study drug administration. 6\. Presence of active autoimmune diseases or a history thereof, excluding vitiligo, resolved childhood asthma, or resolved atopic diseases. Patients with asthma requiring intermittent bronchodilator therapy or other interventions are also excluded. 7\. Active infectious processes necessitating antimicrobial therapy, including the use of antibacterial, antiviral, or antifungal agents. 8\. History of immunodeficiency, including HIV seropositivity or other acquired and congenital immunodeficiency disorders. 9\. Uncontrolled cardiac symptoms or diseases, such as NYHA class II or higher heart failure, unstable angina, myocardial infarction within the past year, atrial fibrillation, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, PR interval greater than 250 ms, or QTc interval ≥470 ms. 10\. A history of arterial or venous thromboembolic events within the past 6 months. 11\. Poorly controlled hypertension despite antihypertensive therapy (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg). 12\. Proteinuria of 2+ or higher and a 24-hour urinary protein excretion exceeding 1.0 g. 13\. Coagulopathy (INR \>2.0, PT \>16 seconds), a bleeding diathesis, or concurrent anticoagulation or thrombolytic therapy. 14\. Bilateral hydronephrosis, unless resolved by unilateral stent placement or percutaneous nephrostomy, or deemed mild and without clinical significance by the investigator. 15\. Contraindications to chemotherapy administration. 16. Contraindications to receiving brachytherapy. 17. History of other malignancies within the past 5 years, except for basal cell carcinoma and squamous cell carcinoma of the skin. 18\. Administration of live vaccines within 4 weeks preceding the first dose of the trial medication. Inactivated seasonal influenza vaccines are permissible. 19\. History of substance abuse that has not been successfully managed or presence of psychiatric disorders that may interfere with study participation. 20\. Any medical, psychiatric, or social conditions deemed by the investigator to potentially impact the subject's ability to provide informed consent, participate fully in the study, or affect the interpretability of the study results.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

More trials for these conditions

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