New hope for cervical cancer patients who Can't take chemo
NCT ID NCT07450963
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests a drug called cadonilimab combined with radiation therapy for women with advanced cervical cancer who cannot receive standard chemotherapy due to age or health issues. The study will enroll 45 participants and measure how many have a complete response (no cancer detected) after treatment. The goal is to see if this combination can improve outcomes compared to radiation alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cadonilimab (a drug that helps the immune system fight cancer)
- What this could lead to
- If successful, this could offer a new treatment option for cervical cancer patients who cannot receive standard chemotherapy, potentially improving tumor shrinkage and long-term control.
- What could go wrong
- This is a small, early-phase trial (45 people) with no control group. The combination may not work better than radiotherapy alone, and side effects from the immune drug could be serious.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2034
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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. Female, age ≥18 years. 2. Histologically confirmed cervical squamous cell carcinoma or adenosquamous carcinoma. 3. FIGO 2018 stage IB3-IVA, or medically inoperable disease requiring definitive radiotherapy. 4. ECOG performance status 0-2, life expectancy ≥6 months. 5. Presence of at least one absolute or relative contraindication to concurrent cisplatin based chemotherapy, defined as: * Age ≥70 years; OR * Renal impairment: serum creatinine \>1.5 × upper limit of normal (ULN) or calculated creatinine clearance (CrCl) \<50 mL/min (Cockcroft Gault); OR * Cardiac dysfunction: New York Heart Association class ≥II; OR * Prior allergic reaction to platinum agents; OR * Patient refusal of chemotherapy after thorough counselling. 6. Adequate organ function: * Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome) * AST and ALT ≤2.5 × ULN 7. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: 1. Prior or concurrent invasive malignancy unless disease free for ≥5 years (exceptions: non melanoma skin cancer, cured in situ carcinoma). 2. No histological confirmation of cervical cancer. 3. Prior exposure to anti PD 1/PD L1, anti CTLA 4, or other immune checkpoint inhibitors. 4. Congenital or acquired immunodeficiency (e.g., HIV infection). 5. Active hepatitis B (HBsAg positive with detectable HBV DNA) or hepatitis C (HCV RNA positive). 6. Pregnancy or lactation (negative serum/urine β hCG required for premenopausal women). 7. Severe uncontrolled comorbidities precluding safe radiotherapy: * Unstable angina, myocardial infarction, or congestive heart failure requiring hospitalisation within 6 months * Acute bacterial or systemic fungal infection * Chronic obstructive pulmonary disease exacerbation requiring hospitalisation * Active connective tissue disease (e.g., systemic lupus erythematosus, scleroderma) 8. Psychiatric illness or social condition that would limit study compliance. 9. Inability to understand the study purpose or refusal to sign informed consent. 10. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
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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.
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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.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Immunotherapy added to chemo aims to boost cervical cancer remission
- Could vitamin d predict cervical cancer treatment success?
- Can a triple-threat approach wipe out cervical cancer before surgery?
- Particle beam and immune therapy join forces against cervical cancer
- Dual immunotherapy plus chemo may shrink cervical tumors before surgery