Cervical CancerPhase 2NCT07167160
Chemo-immunotherapy for Cervical Cancer Stage IIICp Trial
A Phase 2 study testing Camrelizumab combined with chemotherapy in people with Cervical Cancer and Immunochemotherapy, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
Efficacy evaluation of camrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer, Immunochemotherapy
- What is being tested?
- Camrelizumab combined with chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 31 Dec 2029
- 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
- Patients with cervical cancer staged FIGO2018 IIIC1p or IIIC2p after radical surgery;
- Positive PD-L1 expression;
- ECOG score ≤1
Who cannot join
- Positive parametrium or surgical margin;
- Incomplete radical surgery;
- Residual target lesions;
- Active autoimmune disease or autoimmune disease requiring systemic treatment;
- Previous treatment with immune checkpoint inhibitors.
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
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Tingting Chen, 86-13738102530, 11318160@zju.edu.cn
About this study
Official title: Camrelizumab Combined With Chemotherapy for Adjuvant Treatment of Cervical Cancer Patients With Pathologically Confirmed Lymph Node Positivity After Stage Surgery: A Prospective, Single-Arm, Multicenter, Phase II Clinical Trial
Efficacy evaluation of camrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery.
- Conditions
- Cervical Cancer, Immunochemotherapy
- Being tested
- Camrelizumab combined with chemotherapy
- 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.
Camrelizumab combined with chemotherapyDrug
Camrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy group | Experimental | Not described Receives: Drug: Camrelizumab combined with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival rate
Measured: from enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start10 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167160
- Sponsor's protocol ID
- IRB-20250023
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen L, Chen T, Tu N, Dong L, Zhang Y, Wang H, Shen Y. Camrelizumab combined with chemotherapy as postoperative adjuvant therapy after radical surgery for cervical cancer patients with pathologically positive lymph nodes: a prospective multicenter phase II clinical trial. J Gynecol Oncol. 2026 Jul 9. doi: 10.3802/jgo.2027.38.e1. Online ahead of print.
PubMed 42471761
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Chemotherapy for Adjuvant Treatment of Cervical Cancer Patients With Pathologically Confirmed Lymph Node Positivity After Stage Surgery: A Prospective, Single-Arm, Multicenter, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07167160
- Acronym / sponsor ID
- IRB-20250023
- Conditions
- Cervical Cancer, Immunochemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Sep 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.
Efficacy evaluation of camrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy group | Experimental | Drug: Camrelizumab combined with chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with cervical cancer staged FIGO2018 IIIC1p or IIIC2p after radical surgery;
- Positive PD-L1 expression;
- ECOG score ≤1
Key exclusion criteria (5 listed)
- Positive parametrium or surgical margin;
- Incomplete radical surgery;
- Residual target lesions;
- Active autoimmune disease or autoimmune disease requiring systemic treatment;
- Previous treatment with immune checkpoint inhibitors.
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 |
|---|---|---|
| Camrelizumab combined with chemotherapyCamrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery | Drug | chemotherapy group |
Primary outcome
3-year disease-free survival rate
Time frame: from enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 100 months
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 18 Dec 2025.
- Derived from this study: PubMed 42471761Chen L, Chen T, Tu N, Dong L, Zhang Y, Wang H, Shen Y. Camrelizumab combined with chemotherapy as postoperative adjuvant therapy after radical surgery for cervical cancer patients with pathologically positive lymph nodes: a prospective multicenter phase II clinical trial. J Gynecol Oncol. 2026 Jul 9. doi: 10.3802/jgo.2027.38.e1. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, China
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 Camrelizumab combined with chemotherapy in people with Cervical Cancer and Immunochemotherapy, run by Women's Hospital School Of Medicine Zhejiang 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 3 inclusion and 5 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 18 Dec 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival rate (time frame: from enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07167160, which also lists 1 linked publication.
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 18 Dec 2025.