Cervical CancerPhase 2NCT06251388
A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical Cancer
A Phase 2 study testing AK104 in people with Cervical Cancer, run by West China Second University Hospital at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of concurrent chemoradiotherapy（CCRT）followed by cadonilimab（AK104) in high risk local advanced cervical cancer. Participants received CCRT，efficacy evaluation of CCRT was no disease progression who maintained with AK104（10.0 mg/kg，Q3W）until drug exposure over 1 years… 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?
- AK104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 1 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Voluntary agreement to provide written informed consent.
- female, Age 18 -75 years.
- Predicted survival ≥ 3 month.
- Histologically and/or cytologically confirmed Squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, FIGO 2018 stage III-IVA.
- Unable to undergo curative surgery，Pior not received systemic therapy before CCRT, Including but not limited to radiotherapy, chemotherapy, immunotherapy, and biological therapy,etc.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
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- Have at least one evaluable lesion (RECIST 1.1 criteria)
- Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
- participants are eligible to participate if they agree to the contraception use as per study protocol.
- Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
Who cannot join
- Has received other antitumor therapy before CCRT.
- Therapeutic evaluation of CCRT was disease progression.
- Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, and Ox40 . etc.), immune cell therapy. etc. Any tumor immune mechanisms treatment .
- With brain metastases.
- Previously received allogeneic stem cell or parenchymal organ transplantation.
- Previously or currently suffering from congenital or acquired immunodeficiency diseases.
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- known or suspected to have a history of allergies to similar drugs, or has a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to excipients of the study drug.
- Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
- Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- Within the 6 months prior to enrollment, has serious cardiovascular events such as pulmonary embolism, acute myocardial infarction, congestive heart failure (New York Heart Association grade III or IV), and ≥ 2 grade ventricular arrhythmias.
- Cerebrovascular accident within 6 months prior to enrollment.
- Active infection requiring systemic treatment.
- Uncontrolled hypertension, diabetes, Interstitial lung Disease, non infectious pneumonia , pulmonary fibrosis, acute lung disease, etc.
- Required systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to enter the trial.
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Pregnancy or lactation.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
Rutie Yin, Clinical Professor contact
China1 site, 1 recruiting
- Recruiting
West China Second University Hospital
Chengdu, Sichuan, 610041
Rutie Yin, Clinical Professor, yrtt2013@163.com
Rutie Yin, Clinical Professor
About this study
Official title: A Prospective, Single Arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104) for Newly Diagnosed Local Advanced Cervical Cancer
This study will evaluate the efficacy and safety of concurrent chemoradiotherapy（CCRT）followed by cadonilimab（AK104) in high risk local advanced cervical cancer.
Participants received CCRT，efficacy evaluation of CCRT was no disease progression who maintained with AK104（10.0 mg/kg，Q3W）until drug exposure over 1 years or disease progression or intolerable toxicity.
- Conditions
- Cervical Cancer
- Being tested
- AK104
- 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.
AK104Drug
Also called Cadonilimab Injection
AK104（10.0 mg/kg，intravenous (IV) infusion，Q3W）maintained with no more than 1 year.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | AK104（10.0 mg/kg，intravenous (IV) infusion，Q3W） after CCRT Receives: Drug: AK104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Baseline up to approximately 24 months.
Secondary outcomes (4)
Objective response rate assessed by Investigator
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Measured: Baseline up to approximately 12 months.
Disease control rate
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
Measured: Baseline up to approximately 12 months.
Overall survival
OS is the time from randomization to death due to any cause
Measured: Baseline up to approximately 48 months.
Safety and adverse reactions of Cadonilimab
According to CTCAE v5.0, any adverse events that occur to all subjects during the study period will be recorded. We recorded the clinical manifestation characteristics, severity, onset time, duration, treatment method and prognosis, and determined the correlation with Cadonilimab.
Measured: Baseline up to approximately 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Oct 2026 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of North Sichuan Medical College, The Affiliated Hospital Of Southwest Medical University
- Responsible party
- Principal investigator, Rutie Yin, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251388
- Sponsor's protocol ID
- WCSUH20231212
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104) for Newly Diagnosed Local Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT06251388
- Acronym / sponsor ID
- WCSUH20231212
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Collaborators
- Affiliated Hospital of North Sichuan Medical College, The Affiliated Hospital Of Southwest Medical University
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Feb 2024 (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 will evaluate the efficacy and safety of concurrent chemoradiotherapy（CCRT）followed by cadonilimab（AK104) in high risk local advanced cervical cancer.
Participants received CCRT，efficacy evaluation of CCRT was no disease progression who maintained with AK104（10.0 mg/kg，Q3W）until drug exposure over 1 years or disease progression or intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: AK104AK104（10.0 mg/kg，intravenous (IV) infusion，Q3W） after CCRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary agreement to provide written informed consent.
- female, Age 18 -75 years.
- Predicted survival ≥ 3 month.
- Histologically and/or cytologically confirmed Squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, FIGO 2018 stage III-IVA.
- Unable to undergo curative surgery，Pior not received systemic therapy before CCRT, Including but not limited to radiotherapy, chemotherapy, immunotherapy, and biological therapy,etc.
Key exclusion criteria (18 listed)
- Has received other antitumor therapy before CCRT.
- Therapeutic evaluation of CCRT was disease progression.
- Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, and Ox40 . etc.), immune cell therapy. etc. Any tumor immune mechanisms treatment .
- With brain metastases.
- Previously received allogeneic stem cell or parenchymal organ transplantation.
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 |
|---|---|---|
| AK104Also: Cadonilimab InjectionAK104（10.0 mg/kg，intravenous (IV) infusion，Q3W）maintained with no more than 1 year. | Drug | treatment group |
Primary outcome
Progression-free survival
Time frame: Baseline up to approximately 24 months.
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
4 secondary outcomes
Objective response rate assessed by Investigator
Time frame: Baseline up to approximately 12 months.
Disease control rate
Time frame: Baseline up to approximately 12 months.
Overall survival
Time frame: Baseline up to approximately 48 months.
Safety and adverse reactions of Cadonilimab
Time frame: Baseline up to approximately 48 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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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. This study is not recruiting at the moment.
Rutie Yin, Clinical Professor contact
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 AK104 in people with Cervical Cancer, run by West China Second University Hospital 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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rutie Yin, Clinical Professor (yrtt2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Baseline up to approximately 24 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 9 Feb 2024.