Cervical CancerPhase 2NCT07617818
QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy for Cervical Cancer
A Phase 2 study testing QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy in people with Cervical Cancer and Neoadjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Neoadjuvant Therapy, Immunotherapy
- What is being tested?
- QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-65 years.
- Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- FIGO 2018 stage IB1, IB2, or IB3 cervical cancer.
- Pelvic MRI completed before enrollment.
- ECOG performance status of 0-2.
- Adequate organ and bone marrow function.
- No prior immunotherapy for malignant tumors.
- Ability to understand and willingness to sign written informed consent.
Who cannot join
- Presence of uncontrolled concomitant malignancies.
- Active autoimmune disease or history of autoimmune disease with potential recurrence.
- Interstitial lung disease or uncontrolled pneumonitis.
- Active hepatitis B or hepatitis C infection.
- Known HIV infection.
- Receipt of live vaccines within 30 days before first dose.
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- Uncontrolled cardiovascular disease.
- Known hypersensitivity to study drugs.
- Any condition that, in the investigator's judgment, may interfere with study participation or interpretation of results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II, Single-Arm Study of QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy Prior to Conservative Surgery for FIGO 2018 Stage IB1-IB3 Cervical Cancer (CERVINA Study)
This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
The primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile.
Additionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H/dMMR status, and vaginal microbiota before and after treatment.
Read the detailed description
Cervical cancer remains one of the most common gynecologic malignancies worldwide. Neoadjuvant chemotherapy (NACT) has demonstrated favorable response rates in locally advanced cervical cancer; however, pathological complete response (pCR) rates remain limited.
QL1706 is a novel bifunctional PD-1/CTLA-4 antibody combination developed using the MabPair® platform. It consists of the anti-PD-1 antibody iparomlimab and the anti-CTLA-4 antibody tuvonralimab. Previous studies have demonstrated promising antitumor activity in recurrent or metastatic cervical cancer.
This study aims to investigate whether the addition of QL1706 to cisplatin/paclitaxel neoadjuvant therapy can improve pathological response and clinical outcomes in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
Approximately 50 patients will be enrolled. Eligible patients will receive neoadjuvant QL1706 combined with cisplatin and paclitaxel followed by radical surgery. Efficacy will be evaluated using RECIST v1.1 and pathological assessment. Safety will be assessed according to CTCAE v5.0.
Exploratory translational studies will evaluate immune microenvironment changes, molecular biomarkers, and vaginal microbiota alterations associated with treatment response.
- Conditions
- Cervical Cancer, Neoadjuvant Therapy, Immunotherapy
- Being tested
- QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy
- 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.
QL1706 + Cisplatin/Paclitaxel Neoadjuvant TherapyDrug
QL1706 is a bifunctional PD-1/CTLA-4 antibody combination consisting of iparomlimab and tuvonralimab.
Drug: Cisplatin Cisplatin administered as part of neoadjuvant chemotherapy.
Drug: Paclitaxel Paclitaxel administered as part of neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy Receives: Drug: QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Proportion of patients achieving pathological complete response after neoadjuvant therapy.
Measured: At surgery following completion of neoadjuvant therapy
Secondary outcomes (5)
Objective Response Rate (ORR)
Proportion of patients achieving complete or partial response according to RECIST v1.1.
Measured: During neoadjuvant treatment period
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression or death.
Measured: Up to 3 years
3-Year Pelvic Recurrence Rate
Proportion of patients with pelvic recurrence within 3 years.
Measured: 3 years
Adverse Events
Incidence and severity of adverse events graded according to CTCAE v5.0.
Measured: From informed consent through 30 days after last treatment dose
Overall Survival (OS)
Time from treatment initiation to death from any cause
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Dec 2029 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianwei Zhou, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617818
- Sponsor's protocol ID
- CERVINA Study
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Arm Study of QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy Prior to Conservative Surgery for FIGO 2018 Stage IB1-IB3 Cervical Cancer (CERVINA Study)
- ClinicalTrials.gov ID
- NCT07617818
- Acronym / sponsor ID
- CERVINA Study
- Conditions
- Cervical Cancer, Neoadjuvant Therapy, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 1 Jun 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 is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
The primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile.
Additionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H/dMMR status, and vaginal microbiota before and after treatment.
Detailed description
Cervical cancer remains one of the most common gynecologic malignancies worldwide. Neoadjuvant chemotherapy (NACT) has demonstrated favorable response rates in locally advanced cervical cancer; however, pathological complete response (pCR) rates remain limited.
QL1706 is a novel bifunctional PD-1/CTLA-4 antibody combination developed using the MabPair® platform. It consists of the anti-PD-1 antibody iparomlimab and the anti-CTLA-4 antibody tuvonralimab. Previous studies have demonstrated promising antitumor activity in recurrent or metastatic cervical cancer.
This study aims to investigate whether the addition of QL1706 to cisplatin/paclitaxel neoadjuvant therapy can improve pathological response and clinical outcomes in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
Approximately 50 patients will be enrolled. Eligible patients will receive neoadjuvant QL1706 combined with cisplatin and paclitaxel followed by radical surgery. Efficacy will be evaluated using RECIST v1.1 and pathological assessment. Safety will be assessed according to CTCAE v5.0.
Exploratory translational studies will evaluate immune microenvironment changes, molecular biomarkers, and vaginal microbiota alterations associated with treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: QL1706 + Cisplatin/Paclitaxel Neoadjuvant TherapyQL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged 18-65 years.
- Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- FIGO 2018 stage IB1, IB2, or IB3 cervical cancer.
- Pelvic MRI completed before enrollment.
- ECOG performance status of 0-2.
Key exclusion criteria (9 listed)
- Presence of uncontrolled concomitant malignancies.
- Active autoimmune disease or history of autoimmune disease with potential recurrence.
- Interstitial lung disease or uncontrolled pneumonitis.
- Active hepatitis B or hepatitis C infection.
- Known HIV infection.
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 |
|---|---|---|
| QL1706 + Cisplatin/Paclitaxel Neoadjuvant TherapyQL1706 is a bifunctional PD-1/CTLA-4 antibody combination consisting of iparomlimab and tuvonralimab. Drug: Cisplatin Cisplatin administered as part of neoadjuvant chemotherapy. Drug: Paclitaxel Paclitaxel administered as part of neoadjuvant chemotherapy. | Drug | Experimental Arm |
Primary outcome
Pathological Complete Response (pCR)
Time frame: At surgery following completion of neoadjuvant therapy
Proportion of patients achieving pathological complete response after neoadjuvant therapy.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: During neoadjuvant treatment period
Progression-Free Survival (PFS)
Time frame: Up to 3 years
3-Year Pelvic Recurrence Rate
Time frame: 3 years
Adverse Events
Time frame: From informed consent through 30 days after last treatment dose
Overall Survival (OS)
Time frame: Up to 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 1 Jun 2026.
- 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.
Jianwei Zhou, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy in people with Cervical Cancer and Neoadjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Zhigang Zhang, MD (86057189713631, zzg2011@zju.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) (time frame: At surgery following 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 1 Jun 2026.