New drug combo shows promise against advanced cervical cancer in early trial
NCT ID NCT06511726
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a new immunotherapy drug (cadonilimab) to chemotherapy before the usual chemoradiation can shrink tumors better in people with locally advanced cervical cancer. About 29 participants will receive the combination, then standard treatment. The goal is to see if this approach improves response rates and delays cancer progression.
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 29 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Apr 2029
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. Patients with good compliance. 2. Age ≥ 18 years (calculated on the day of signing the informed consent). 3. Histologically or pathologically diagnosed with cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) and measurable lesions. 4. Initial diagnosis of stage IB3-IVA (according to FIGO 2018 staging). 5. ECOG performance score of 0-2. 6. Main organ functions meet the protocol criteria within 7 days before treatment. Exclusion Criteria: 1. Patients with other histological types of cervical cancer, such as neuroendocrine carcinoma or sarcoma. 2. Evidence of distant metastasis, including groin lymph node metastasis and lymph node metastasis above the L1 level. 3. Previously underwent total hysterectomy (removal of the uterus body + cervix). History of subtotal hysterectomy or cervical wedge resection that preserves the cervix is allowed. 4. With anatomical abnormalities or tumor geometry-related contraindications that prevent the use of brachytherapy. 5. Within 2 years, had other active malignant tumors, except for locally curable tumors that have been cured, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, and ductal carcinoma in situ of the breast. 6. With clinically significant bilateral hydronephrosis that, in the investigator's judgment, cannot be relieved by nephrostomy or ureteral stent placement. 7. Previously received immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies) or any treatment targeting tumor immune mechanisms involving immune co-stimulatory factors (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40). 8. Within 2 weeks, requires the use of glucocorticoids (\> 10 mg/day prednisone or equivalent dose of glucocorticoids) or other immunosuppressive drugs for systemic treatment exceptions include: a) Allowed treatment with inhaled, ophthalmic, or local doses ≤ 10 mg/day prednisone or equivalent dose of glucocorticoids. b) Physiological glucocorticoid replacement therapy at a dose ≤ 10 mg/day prednisone or equivalent dose of glucocorticoids. c) Glucocorticoids used for prophylaxis against hypersensitivity reactions (e.g., premedication for CT scans). 9. Within 2 weeks, received drugs with immunomodulatory effects (e.g., thymosin, interferon, interleukin-2). 10. Presence of active systemic infections requiring systemic treatment (including active pulmonary tuberculosis, active syphilis caused by Treponema pallidum, and fungal infections requiring systemic treatment) note: exclusion does not apply to antiviral drugs used for hepatitis B virus infection. 11. Within 4 weeks, experienced severe infections, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia. 12. Within 4 weeks, underwent major surgical treatment (as determined by the investigator), open biopsy, or significant trauma or requires scheduled major surgical treatment during the study. Diagnostic systematic pelvic/aortic lymphadenectomy is allowed. 13. Received live vaccines within 4 weeks . 14. With active or history of documented autoimmune diseases exceptions include: vitiligo, alopecia, psoriasis, or eczema that do not require systemic treatment hypothyroidism caused by autoimmune thyroiditis requiring stable dose of hormone replacement therapy type 1 diabetes requiring stable dose of insulin replacement therapy. 15. Any of the following cardiovascular diseases: a) New York Heart Association (NYHA) functional classification ≥ II for heart failure. b) Presence of severe arrhythmias requiring long-term drug intervention asymptomatic patients with stable ventricular rate in atrial fibrillation are allowed to enroll. c) Occurrence of cerebrovascular events (CVA) within 6 months . d) Left ventricular ejection fraction (LVEF) \< 50%. 16. Known primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test. 17. Subjects with active hepatitis B virus (HBV) infection, non-active or asymptomatic carriers of hepatitis B surface antigen (HBsAg) with HBV DNA \> 1000 IU/mL, and subjects with active hepatitis C virus (HCV) infection. Note: Non-active or asymptomatic carriers with treated and stable hepatitis B infection with HBV DNA ≤ 1000 IU/mL are allowed to enroll. Subjects with cured hepatitis C infection, positive HCV antibody (HCVAb), and negative HCV RNA are allowed to enroll. 18. With active or documented history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or active diverticulitis. 19. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 20. Known history of severe hypersensitivity reactions to other monoclonal antibodies. 21. Pregnant or breastfeeding women. 22. The investigator believes that there may be risks associated With receiving the investigational drug or any condition that may interfere With the evaluation of the investigational drug, subject safety, or interpretation of study results (such as having other severe diseases or mental disorders).
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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.
Contacts and locations
Locations
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Sun Yat-sen Memorial hosipital
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Target immunotherapy added to standard care for aggressive cervical cancer
- Can pulsed radiation extend life in metastatic cervical cancer?
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Smart speculum could bring cervical cancer screening to remote areas
- Your gut bacteria may hold the key to whether immunotherapy works