New combo therapy aims to boost survival in advanced cervical cancer
NCT ID NCT06416696
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cervical cancers are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
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.
- Could a condensed radiation course after cervical cancer surgery be just as safe and effective?
- Could 3 radiation doses beat 4 for cervical cancer?
- Nurse navigators boost cervical cancer screening in study
- At-Home HPV tests could boost cervical cancer screening in border communities
- Rare surgery for recurrent cancer: how does it affect quality of life?
- Can a Nurse-Led program transform Women's health in hong kong?