Locally Advanced Cervical CarcinomaPhase 3NCT07400536
A Clinical Study on the Treatment of LACC With Cadonilimab Combined With Chemotherapy Followed by CCRT
A Phase 3 study testing standard EBRT+Brachytherapy, Concurrent chemotherapy and Immune induction therapy in people with Locally Advanced Cervical Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Locally Advanced Cervical Carcinoma
- What is being tested?
- standard EBRT+Brachytherapy, Concurrent chemotherapy and Immune induction therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2026to 20 Jul 2032
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be enrolled, subjects had to meet all of the following criteria:
- Female, aged 18-70 years (inclusive of cutoff values);
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix;
- Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy;
- At least one measurable lesion according to RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1;
- Have adequate organ function.
Who cannot join
- Subjects were excluded from the study if they met any of the following criteria:
- Distant metastatic disease (including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 pyramid in the proximal cephalic region, according to FIGO 2018 stage IVB);
- He had undergone total hysterectomy (removal of the corpus uteri and cervix);
- Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities;
- Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
- Had any condition that was deemed by other investigators to be ineligible for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guiling Li, PHD contact
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Yuling Zhang, (+86)027-85726685, whuniongcp01@126.com
About this study
Official title: A Phase III, Multicenter, Open-label, Randomized Controlled Clinical Study on the Treatment of Locally Advanced Cervical Cancer With Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy
This study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer.
- Conditions
- Locally Advanced Cervical Carcinoma
- Being tested
- standard EBRT+Brachytherapy, Concurrent chemotherapy, Immune induction therapy, Reduced dose radiotherapy, Dose reduction concurrent chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard EBRT+BrachytherapyRadiation
EBRT: 45-50.4Gy, Brachytherapy: 7Gy×4 or 6Gy
×5
Concurrent chemotherapyDrug
Cisplatin 40mg/m2, qw×5
Immune induction therapyDrug
Cadonilimab （Moderate dose）+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6
Reduced dose radiotherapyRadiation
EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4
Dose reduction concurrent chemotherapyDrug
cisplatin 25mg/m2, qw×5
Immunomaintenance therapyDrug
Cadonilimab （Moderate dose）×9 or half a year
| Study group | Role | What they receive |
|---|---|---|
| Standard concurrent chemoradiotherapy（CCRT） | Active comparator | Accept standard concurrent chemoradiotherapy Receives: Radiation: standard EBRT+Brachytherapy; Drug: Concurrent chemotherapy |
| Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab | Experimental | Undergo immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy. Receives: Drug: Immune induction therapy; Radiation: Reduced dose radiotherapy; Drug: Dose reduction concurrent chemotherapy; Drug: Immunomaintenance therapy |
| Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab | Experimental | Undergo immune induction chemotherapy combined with reduced-dose radiotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy. Receives: Drug: Immune induction therapy; Radiation: Reduced dose radiotherapy; Drug: Immunomaintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Measured: Up to approximately 55 months
Secondary outcomes (5)
Objective Response Rate (ORR) per RECIST 1.1
Assessed by investigators
Measured: Up to approximately 55 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 55 months
Duration of Response (DOR) per RECIST 1.1
Assessed by investigators
Measured: Up to approximately 3 years
Time to Response (TTR) per RECIST 1.1
Assessed by investigators
Measured: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST 1.1
Assessed by investigators
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start24 Apr 2026
- Primary completion18 Jul 2028 (estimated)
- Study completion20 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Akesobio
- Responsible party
- Principal investigator, Guiling Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Guiling Li, PHD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400536
- Sponsor's protocol ID
- AK104-IIT-CC-001
- Status last verified
- May 2026
- First submitted
- 2 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Open-label, Randomized Controlled Clinical Study on the Treatment of Locally Advanced Cervical Cancer With Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT07400536
- Acronym / sponsor ID
- AK104-IIT-CC-001
- Conditions
- Locally Advanced Cervical Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Akesobio
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 18 Jul 2028 (estimated)
- Study completion
- 20 Jul 2032 (estimated)
- First posted
- 10 Feb 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 study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard concurrent chemoradiotherapy（CCRT） | Active comparator | Radiation: standard EBRT+Brachytherapy, Drug: Concurrent chemotherapyAccept standard concurrent chemoradiotherapy |
| Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab | Experimental | Drug: Immune induction therapy, Radiation: Reduced dose radiotherapy, Drug: Dose reduction concurrent chemotherapy, Drug: Immunomaintenance therapyUndergo immune induction chemotherapy combined with reduced-dose radiotherapy and reduced-dose concurrent chemotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy. |
| Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab | Experimental | Drug: Immune induction therapy, Radiation: Reduced dose radiotherapy, Drug: Immunomaintenance therapyUndergo immune induction chemotherapy combined with reduced-dose radiotherapy, and receive immune maintenance therapy after the completion of radiotherapy and chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, aged 18-70 years (inclusive of cutoff values);
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix;
- Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy;
- At least one measurable lesion according to RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1;
Key exclusion criteria (6 listed)
- Distant metastatic disease (including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 pyramid in the proximal cephalic region, according to FIGO 2018 stage IVB);
- He had undergone total hysterectomy (removal of the corpus uteri and cervix);
- Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities;
- Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
- Had any condition that was deemed by other investigators to be ineligible for participation in the trial.
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 |
|---|---|---|
| standard EBRT+BrachytherapyEBRT: 45-50.4Gy, Brachytherapy: 7Gy×4 or 6Gy ×5 | Radiation | Standard concurrent chemoradiotherapy（CCRT） |
| Concurrent chemotherapyCisplatin 40mg/m2, qw×5 | Drug | Standard concurrent chemoradiotherapy（CCRT） |
| Immune induction therapyCadonilimab （Moderate dose）+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6 | Drug | Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab, Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab |
| Reduced dose radiotherapyEBRT: 45-50.4Gy; Brachytherapy: 6Gy×4 | Radiation | Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab, Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab |
| Dose reduction concurrent chemotherapycisplatin 25mg/m2, qw×5 | Drug | Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab |
| Immunomaintenance therapyCadonilimab （Moderate dose）×9 or half a year | Drug | Cadonilimab+Induction chemotherapy+reduced-dose CCRT+Cadonilimab, Cadonilimab+Induction chemotherapy+reduced-dose radiotherapy+Cadonilimab |
Primary outcome
Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV)
Time frame: Up to approximately 55 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
5 secondary outcomes
Objective Response Rate (ORR) per RECIST 1.1
Time frame: Up to approximately 55 months
Overall Survival (OS)
Time frame: Up to approximately 55 months
Duration of Response (DOR) per RECIST 1.1
Time frame: Up to approximately 3 years
Time to Response (TTR) per RECIST 1.1
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST 1.1
Time frame: Up to approximately 3 years
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 13 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Guiling Li, PHD contact
Guiling Li, PHD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing standard EBRT+Brachytherapy, Concurrent chemotherapy and Immune induction therapy in people with Locally Advanced Cervical Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 May 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ting Liu, MD (+86 (0760) 8987 3999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV) (time frame: Up to approximately 55 months). 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 13 May 2026.