Cervical CarcinomaPhase 2NCT07088731
Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
A Phase 2 study testing Sintilimab and Concurrent chemo-radiotherapy in people with Cervical Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
For locally advanced cervical cancer, there are two main treatment options: One is radical chemoradiotherapy (a combination of radiotherapy and chemotherapy aimed at curing the disease). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- Sintilimab and Concurrent chemo-radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to Jul 2027
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years and ≤ 70 years;
- Cervical cancer with pathological types being squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- Staged IB3 or IIA2 according to the FIGO 2018 staging system, as assessed by the investigator;
- ECOG performance status of 0-2, or KPS score ≥ 70;
- Expected survival time of more than 3 months;
- Having at least one measurable lesion in accordance with RECIST 1.1;
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- Laboratory test results meeting the following criteria without drug intervention:
- Hemoglobin ≥ 90 g/dl, neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L;
- Creatinine ≤ 1.5 times the upper limit of normal range;
- Total bilirubin, alanine transaminase (ALT), and aspartate transaminase (AST) < 2 times the upper limit of normal;
- Postmenopausal, or reproductive-aged women who meet all the following conditions: non-lactating, not pregnant, and able to use effective contraceptive measures during the study treatment period;
- Voluntarily participating in this study and signing the informed consent form.
Who cannot join
- Participated in other clinical trials within 30 days before receiving the first dose of chemotherapy drugs or during the treatment period.
- Previously received any other anti-tumor treatment for cervical cancer.
- Non-HPV-related cervical cancer.
- Needing to receive other anti-tumor treatments during the study treatment period.
- Patients with known allergies to the active ingredients of the study drugs or their excipients.
- Diagnosed with other malignant tumors in the past 5 years (except those judged to be cured by the investigator).
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- Active infections requiring systemic treatment.
- Positive for human immunodeficiency virus (HIV) antibody.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody.
- Peripheral neuropathy with a grade of ≥ 2 according to the NCI-CTCAE (Version 5.0).
- Concurrent diseases or abnormal test results that interfere with the subject's ability to receive anti-tumor treatment as judged by the investigator, such as the estimated inability of the subject to tolerate at least 2 cycles of neoadjuvant chemotherapy plus surgery or concurrent chemoradiotherapy, etc.
- Participation in this study is deemed not conducive to the maximum benefit of the subject as judged by the investigator.
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
Department of Gynecological Oncology
Beijing
Guangwen Yuan, doctoral, +86 136 9368 4116, william327@126.com
About this study
Official title: A Prospective, Single-Center, Randomized Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
For locally advanced cervical cancer, there are two main treatment options:
One is radical chemoradiotherapy (a combination of radiotherapy and chemotherapy aimed at curing the disease).
Read more
The other is having neoadjuvant treatment first (treatment given before the main surgery to shrink the tumor) followed by radical surgery.
So far, there's no clear answer on which of these two options is better. In general, cervical cancer responds well to immunotherapy. But we still don't know for sure if adding immunotherapy to neoadjuvant chemotherapy can improve the treatment effect for locally advanced cervical cancer, or even make it better than radical chemoradiotherapy.
This study aims to compare the effects of two approaches: radical chemoradiotherapy versus neoadjuvant chemotherapy plus immunotherapy followed by surgery.
- Conditions
- Cervical Carcinoma
- Being tested
- Sintilimab, Concurrent chemo-radiotherapy
- Keywords
- locally advanced, neoadjuvent chemotherapy, neoadjuvent immunotherapy, CCRT
- 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.
SintilimabDrug
Also called Nab-paclitaxel, cisplatin
neoadjuvent chemotherapy plus sintilimab for 2 cycles followed by radical surgery
Concurrent chemo-radiotherapyRadiation
EBRT+BT+cisplatin
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvent arm | Experimental | Not described Receives: Drug: Sintilimab |
| CCRT arm | Active comparator | Not described Receives: Radiation: Concurrent chemo-radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Progression-Free Survival Rate
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUANG WEN YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088731
- Sponsor's protocol ID
- 25/275-5221
- Status last verified
- Sep 2025
- First submitted
- 19 Jul 2025
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Randomized Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT07088731
- Acronym / sponsor ID
- 25/275-5221
- Conditions
- Cervical Carcinoma
- Keywords
- locally advanced, neoadjuvent chemotherapy, neoadjuvent immunotherapy, CCRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Jul 2025 (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.
For locally advanced cervical cancer, there are two main treatment options:
One is radical chemoradiotherapy (a combination of radiotherapy and chemotherapy aimed at curing the disease).
The other is having neoadjuvant treatment first (treatment given before the main surgery to shrink the tumor) followed by radical surgery.
So far, there's no clear answer on which of these two options is better. In general, cervical cancer responds well to immunotherapy. But we still don't know for sure if adding immunotherapy to neoadjuvant chemotherapy can improve the treatment effect for locally advanced cervical cancer, or even make it better than radical chemoradiotherapy.
This study aims to compare the effects of two approaches: radical chemoradiotherapy versus neoadjuvant chemotherapy plus immunotherapy followed by surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvent arm | Experimental | Drug: Sintilimab |
| CCRT arm | Active comparator | Radiation: Concurrent chemo-radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged ≥ 18 years and ≤ 70 years;
- Cervical cancer with pathological types being squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- Staged IB3 or IIA2 according to the FIGO 2018 staging system, as assessed by the investigator;
- ECOG performance status of 0-2, or KPS score ≥ 70;
- Expected survival time of more than 3 months;
Key exclusion criteria (12 listed)
- Participated in other clinical trials within 30 days before receiving the first dose of chemotherapy drugs or during the treatment period.
- Previously received any other anti-tumor treatment for cervical cancer.
- Non-HPV-related cervical cancer.
- Needing to receive other anti-tumor treatments during the study treatment period.
- Patients with known allergies to the active ingredients of the study drugs or their excipients.
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 |
|---|---|---|
| SintilimabAlso: Nab-paclitaxel, cisplatinneoadjuvent chemotherapy plus sintilimab for 2 cycles followed by radical surgery | Drug | neoadjuvent arm |
| Concurrent chemo-radiotherapyEBRT+BT+cisplatin | Radiation | CCRT arm |
Primary outcome
2-year Progression-Free Survival Rate
Time frame: From enrollment to the end of treatment at 2 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 22 Sep 2025.
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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 Sintilimab and Concurrent chemo-radiotherapy in people with Cervical Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 12 inclusion and 12 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 22 Sep 2025. 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 Guangwen Yuan, doctoral (+86 136 9368 4116, william327@126.com), 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 Rate (time frame: From enrollment to the end of treatment at 2 years). 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 22 Sep 2025.