Cervical NeoplasmsPhase 2NCT07731828
Neoadjuvant Short-course Hypofractionated Radiotherapy Plus Adebrelimab and Platinum Chemotherapy in Locally Advanced Cervical Cancer: A Single-arm Phase II Trial
A Phase 2 study testing Adebrelimab in people with Cervical Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Brief Summary A Phase II Single-Arm Clinical Trial of Short-Course Radiotherapy Combined with Adebrelimab and Platinum-Based Neoadjuvant Therapy for Locally Advanced Cervical Cancer Background \& Objective: This is a single-center, single-arm, Phase II clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Neoplasms
- What is being tested?
- Adebrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Aug 2028
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form prior to any study-specific procedure.
- Female aged 18 to 80 years (inclusive) at the time of signing informed consent.
- Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- Clinical staging of IB3-IIA2, or IIIA without parametrial invasion (according to FIGO 2018 staging system); no pelvic lymph node metastasis confirmed by PET/CT, and no evidence of distant metastasis.
- No prior surgery, radiotherapy, or systemic anti-tumor therapy for locally advanced cervical cancer (LACC).
- At least one measurable lesion meeting RECIST 1.1 evaluation criteria.
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
- Adequate hematological, hepatic, and renal function within 14 days prior to enrollment (details to be confirmed in the full protocol).
Who cannot join
- Pregnant or lactating women, or women who intend to become pregnant during the study period and are unwilling to use effective contraception.
- Known hypersensitivity to adebrelimab, platinum-based drugs (cisplatin or carboplatin), or any component of the concomitant regimens.
- History of other malignant tumors within 5 years prior to enrollment, except for cured non-melanoma skin cancer or cervical intraepithelial neoplasia.
- Uncontrolled severe cardiovascular disease (e.g., NYHA Class III or IV heart failure, unstable angina pectoris, uncontrolled arrhythmias, or myocardial infarction within 6 months).
- Active autoimmune disease requiring systemic immunosuppressive or corticosteroid therapy.
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or uncontrolled HIV infection.
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- Uncontrolled severe infection requiring systemic antibiotic/antiviral therapy at enrollment.
- Prior participation in other clinical trials and received investigational drug within 4 weeks before enrollment.
- Concomitant disease or condition that, in the judgment of the Investigator, would place the subject at undue risk or interfere with the subject's participation in the trial or interpretation of trial results.
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, 1 recruiting
- Recruiting
The Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Qin Qin, +86-15950508512, shuizhuqq@njmu.edu.cn
About this study
Official title: A Single-arm, Phase II Study of Short-course Hypofractionated Radiotherapy Combined With Adebrelimab and Single-agent Platinum Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer
Brief Summary
A Phase II Single-Arm Clinical Trial of Short-Course Radiotherapy Combined with Adebrelimab and Platinum-Based Neoadjuvant Therapy for Locally Advanced Cervical Cancer
Read more
Background \& Objective:
This is a single-center, single-arm, Phase II clinical trial. The primary objective is to evaluate the pathological complete response (pCR) rate (defined as ypT0N0) following neoadjuvant therapy with short-course radiotherapy (SCRT) combined with Adebrelimab (an anti-PD-L1 monoclonal antibody) and single-agent platinum chemotherapy in patients with locally advanced cervical cancer (LACC).
Study Design:
Patients will receive SCRT followed by three cycles of neoadjuvant chemoimmunotherapy. After completion of neoadjuvant treatment, radical hysterectomy with pelvic lymphadenectomy (with or without para-aortic lymphadenectomy) will be performed.
Outcome Measures:
Primary Endpoint: Pathological Complete Response (pCR) rate assessed by a central pathologist.
Secondary Endpoints:
Objective Response Rate (ORR) and R0 resection rate (per RECIST 1.1).
Event-Free Survival (EFS) and 2-year EFS rate.
Incidence and severity of Treatment-Related Adverse Events (TRAEs, per NCI-CTCAE v5.0) and surgical complications (per Clavien-Dindo classification).
Feasibility and implementation rate of different adjuvant treatment strategies based on postoperative risk stratification.
Depth of response (major pathological response, MPR).
Inclusion Criteria:
Key eligibility criteria include:
Newly diagnosed, histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
Clinical stage IB3-IIA2 or IIIA (without parametrial invasion) per FIGO 2018 staging.
No evidence of extrapelvic lymph node metastasis or distant metastasis (confirmed by PET/CT or enhanced CT).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Conditions
- Cervical Neoplasms
- Being tested
- Adebrelimab
- 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.
AdebrelimabDrug
Adebrelimab (1200 mg) is administered intravenously (IV) on Day 1 of each 21-day cycle (Q3W).
Neoadjuvant Phase: Patients receive short-course radiotherapy (30 Gy in 6 fractions) concurrent with 2 cycles of Adebrelimab plus platinum-based chemotherapy (cisplatin or carboplatin).
Adjuvant Phase: Following surgery, patients receive up to 3 additional cycles of Adebrelimab plus platinum. This is followed by maintenance therapy with Adebrelimab monotherapy (Q3W) for a total treatment duration of 1 year. High-risk patients (positive nodes/margins) may receive additional radiotherapy as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab Treatment | Experimental | Not described Receives: Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
Measured: At the time of definitive surgery (approximately 6-8 weeks after completion of neoadjuvant therapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731828
- Sponsor's protocol ID
- 2026-SR-411
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Study of Short-course Hypofractionated Radiotherapy Combined With Adebrelimab and Single-agent Platinum Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT07731828
- Acronym / sponsor ID
- 2026-SR-411
- Conditions
- Cervical Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 28 Jul 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.
Brief Summary
A Phase II Single-Arm Clinical Trial of Short-Course Radiotherapy Combined with Adebrelimab and Platinum-Based Neoadjuvant Therapy for Locally Advanced Cervical Cancer
Background \& Objective:
This is a single-center, single-arm, Phase II clinical trial. The primary objective is to evaluate the pathological complete response (pCR) rate (defined as ypT0N0) following neoadjuvant therapy with short-course radiotherapy (SCRT) combined with Adebrelimab (an anti-PD-L1 monoclonal antibody) and single-agent platinum chemotherapy in patients with locally advanced cervical cancer (LACC).
Study Design:
Patients will receive SCRT followed by three cycles of neoadjuvant chemoimmunotherapy. After completion of neoadjuvant treatment, radical hysterectomy with pelvic lymphadenectomy (with or without para-aortic lymphadenectomy) will be performed.
Outcome Measures:
Primary Endpoint: Pathological Complete Response (pCR) rate assessed by a central pathologist.
Secondary Endpoints:
Objective Response Rate (ORR) and R0 resection rate (per RECIST 1.1).
Event-Free Survival (EFS) and 2-year EFS rate.
Incidence and severity of Treatment-Related Adverse Events (TRAEs, per NCI-CTCAE v5.0) and surgical complications (per Clavien-Dindo classification).
Feasibility and implementation rate of different adjuvant treatment strategies based on postoperative risk stratification.
Depth of response (major pathological response, MPR).
Inclusion Criteria:
Key eligibility criteria include:
Newly diagnosed, histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
Clinical stage IB3-IIA2 or IIIA (without parametrial invasion) per FIGO 2018 staging.
No evidence of extrapelvic lymph node metastasis or distant metastasis (confirmed by PET/CT or enhanced CT).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab Treatment | Experimental | Drug: Adebrelimab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent form prior to any study-specific procedure.
- Female aged 18 to 80 years (inclusive) at the time of signing informed consent.
- Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- Clinical staging of IB3-IIA2, or IIIA without parametrial invasion (according to FIGO 2018 staging system); no pelvic lymph node metastasis confirmed by PET/CT, and no evidence of distant metastasis.
- No prior surgery, radiotherapy, or systemic anti-tumor therapy for locally advanced cervical cancer (LACC).
Key exclusion criteria (9 listed)
- Pregnant or lactating women, or women who intend to become pregnant during the study period and are unwilling to use effective contraception.
- Known hypersensitivity to adebrelimab, platinum-based drugs (cisplatin or carboplatin), or any component of the concomitant regimens.
- History of other malignant tumors within 5 years prior to enrollment, except for cured non-melanoma skin cancer or cervical intraepithelial neoplasia.
- Uncontrolled severe cardiovascular disease (e.g., NYHA Class III or IV heart failure, unstable angina pectoris, uncontrolled arrhythmias, or myocardial infarction within 6 months).
- Active autoimmune disease requiring systemic immunosuppressive or corticosteroid therapy.
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 |
|---|---|---|
| AdebrelimabAdebrelimab (1200 mg) is administered intravenously (IV) on Day 1 of each 21-day cycle (Q3W). Neoadjuvant Phase: Patients receive short-course radiotherapy (30 Gy in 6 fractions) concurrent with 2 cycles of Adebrelimab plus platinum-based chemotherapy (cisplatin or carboplatin). Adjuvant Phase: Following surgery, patients receive up to 3 additional cycles of Adebrelimab plus platinum. This is followed by maintenance therapy with Adebrelimab monotherapy (Q3W) for a total treatment duration of 1 year. High-risk patients (positive nodes/margins) may receive additional radiotherapy as clinically indicated. | Drug | Adebrelimab Treatment |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At the time of definitive surgery (approximately 6-8 weeks after completion of neoadjuvant therapy).
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 28 Jul 2026.
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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 Adebrelimab in people with Cervical Neoplasms, run by The First Affiliated Hospital with Nanjing Medical 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 8 inclusion and 9 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 28 Jul 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 Qin Qin (+86-15950508512, shuizhuqq@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: At the time of definitive surgery (approximately 6-8 weeks after completion of neoadjuvant therapy).). 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 28 Jul 2026.