Cervical CancerPhase 2NCT07649174
Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial
A Phase 2 study testing Neoadjuvant Therapy Plus Surgery and Concurrent Chemoradiotherapy in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
Trial summary
This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Neoadjuvant Therapy Plus Surgery and Concurrent Chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2026to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with previously untreated locally advanced cervical cancer, clinically staged as FIGO 2018 stage IB3, IIA2, IIB, or IIIC1r (tumor diameter >4 cm as assessed by contrast-enhanced pelvic MRI);
- Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- Female patients aged ≥18 and ≤75 years;
- Willing and able to provide written informed consent and comply with study visits and protocol-required procedures;
- Eligible for radical hysterectomy with curative intent;
- At least one measurable lesion according to RECIST version 1.1;
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Estimated life expectancy of at least 6 months;
- Women of childbearing potential must agree to use effective contraception throughout the study period. A negative serum or urine pregnancy test is required before study enrollment.
Who cannot join
- Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma.
- Clinically significant unrecoverable hydronephrosis;
- CNS metastases or leptomeningeal disease;
- Active malignancy within 3 years prior to enrollment (with specified exceptions);
- Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies;
- Major surgery within 4 weeks before study treatment;
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- Severe cardiovascular or cerebrovascular disease;
- Unresolved toxicities from previous anticancer therapy (> Grade 1, CTCAE v5.0);
- Known hypersensitivity to study drugs;
- Serious medical or psychiatric conditions that may interfere with study participation;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, 201101
Xin Wu, Dr, 86 21 33189900, wuxin_fc@fudan.edu.cn
About this study
Official title: Efficacy of Cadonilimab in Combination With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized Phase II Trial
This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- Neoadjuvant Therapy Plus Surgery, Concurrent Chemoradiotherapy
- Keywords
- cervical cancer, Immunotherapy, Neoadjuvant therapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Therapy Plus SurgeryProcedure or surgery
Patients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy/dissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings.
Concurrent ChemoradiotherapyProcedure or surgery
Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy/dissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings. Receives: Procedure: Neoadjuvant Therapy Plus Surgery |
| Control arm | Active comparator | Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy. Receives: Procedure: Concurrent Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival (PFS) rate
The proportion of patients who remain alive without radiologically confirmed disease progression at 2 years after randomization. Disease progression will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on imaging evaluations.
Measured: 2 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start6 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649174
- Sponsor's protocol ID
- FUOBGY-2026-55
- Other IDs
- 2025ZD0544104, 2025YFC3508302
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cadonilimab in Combination With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT07649174
- Acronym / sponsor ID
- FUOBGY-2026-55
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, Immunotherapy, Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 6 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Neoadjuvant Therapy Plus SurgeryPatients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy/dissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings. |
| Control arm | Active comparator | Procedure: Concurrent ChemoradiotherapyPatients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with previously untreated locally advanced cervical cancer, clinically staged as FIGO 2018 stage IB3, IIA2, IIB, or IIIC1r (tumor diameter >4 cm as assessed by contrast-enhanced pelvic MRI);
- Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- Female patients aged ≥18 and ≤75 years;
- Willing and able to provide written informed consent and comply with study visits and protocol-required procedures;
- Eligible for radical hysterectomy with curative intent;
Key exclusion criteria (11 listed)
- Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma.
- Clinically significant unrecoverable hydronephrosis;
- CNS metastases or leptomeningeal disease;
- Active malignancy within 3 years prior to enrollment (with specified exceptions);
- Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant Therapy Plus SurgeryPatients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy/dissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings. | Procedure or surgery | Experimental arm |
| Concurrent ChemoradiotherapyPatients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy. | Procedure or surgery | Control arm |
Primary outcome
2-year progression-free survival (PFS) rate
Time frame: 2 years after randomization
The proportion of patients who remain alive without radiologically confirmed disease progression at 2 years after randomization. Disease progression will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on imaging evaluations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Therapy Plus Surgery and Concurrent Chemoradiotherapy in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Wu (86 21 33189900, wuxin_fc@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (PFS) rate (time frame: 2 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.