Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer (QUARTZ-CC)

June 9, 2026 updated by: Jihong Liu, Sun Yat-sen University

Iparomlimab and Tuvonralimab Plus Paclitaxel and Platinum as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Prospective Single-Arm Phase II Trial

Purpose:

To evaluate the efficacy and safety of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706), a dual PD1and CTLA4 bispecific antibody, in combination with paclitaxel and either cisplatin or carboplatin (TP/TC regimen) for patients with locally advanced cervical cancer.

Eligibility Criteria:

Women aged 18 to 70 years with newly diagnosed, histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), FIGO stage IB3 or IIA2, with no evidence of significant lymph node involvement (pelvic and paraaortic lymph nodes <1.5 cm in short diameter), and who have not received any prior anticancer therapy.

Study Procedures:

Participants will receive up to 4 cycles of QL1706 plus TP/TC chemotherapy (once every 3 weeks) prior to surgery. After 2 cycles, clinical assessment will be performed to evaluate tumor response. If tumor shrinkage is observed, treatment may continue for 2 additional cycles, followed by imaging evaluation. Depending on the response, participants with complete or partial response may undergo less extensive surgery (cervical conization plus sentinel lymph node biopsy) rather than standard radical hysterectomy. After surgery, participants who achieve a major pathological response will receive QL1706 maintenance therapy as a single agent for up to 8 additional cycles (once every 3 weeks). For participants with insufficient tumor response, standard radical hysterectomy will be performed. Postoperative adjuvant therapy (radiation or chemotherapy) will follow standard clinical guidelines.

Primary and Secondary Objectives:

The primary endpoint is the pathological complete response (pCR) rate in the resected tissue following neoadjuvant treatment. Secondary endpoints include safety (treatment related adverse events), objective response rate (ORR), 3 years overall survival, 3 years disease free survival, and quality of life.

Study Duration:

Total participation time depends on treatment response and surgical scheduling, with an expected duration of approximately 9 to 12 months (including neoadjuvant treatment, surgery, and potential maintenance therapy).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Detailed Description Background Cervical cancer remains the fourth most common malignancy among women worldwide. In 2022, approximately 660,000 new cases and 350,000 deaths were reported globally, with the heaviest burden observed in developing regions, particularly Asia, which accounts for nearly 60% of global cases and deaths. China alone contributes 22.8% of global incidence and 16% of global mortality.

Locally advanced cervical cancer (LACC, FIGO stages IB3 and IIA2) constitutes approximately 50% of all cervical cancer cases in China. Current standard of care is concurrent chemoradiotherapy (CCRT); however, 23.3%-34.4% of patients still experience disease recurrence or metastasis. Neoadjuvant chemotherapy (NACT) followed by radical surgery has been investigated as an alternative strategy, yet 9.8%-30.6% of patients fail to respond to NACT, potentially delaying effective local treatment. Moreover, over 30% of patients who undergo surgery require adjuvant radiotherapy, raising concerns regarding treatment burden and health economics.In recent years, immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy. Anti-PD-1/PD-L1 and anti-CTLA-4 antibodies exert complementary mechanisms of action. Emerging evidence supports the combination of neoadjuvant chemotherapy and immunotherapy for LACC. In the PACS study (presented at ASCO 2024), the pathological complete response (pCR) rate was 36.2%, and the optimal pathological response rate (residual tumor <3 mm) was 53.2%. Other studies, including NACI, MITO CERV3, and NATCI, have reported similarly encouraging pCR rates. Given the unmet medical need for more effective and less toxic neoadjuvant regimens, further evaluation of novel immunotherapy combinations such as the dual PD-1/CTLA-4 bispecific antibody iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy is warranted.

Detailed Treatment and Response-Adapted Algorithm Following neoadjuvant treatment (up to 4 cycles of paclitaxel plus cisplatin or carboplatin combined with QL1706), patients undergo clinical assessment after 2 cycles. If tumor shrinkage is observed, patients continue for 2 additional cycles followed by imaging evaluation. Based on imaging response: complete response leads to cervical conization plus sentinel lymph node biopsy or pelvic lymph node dissection; partial response leads to radical hysterectomy or trachelectomy plus sentinel lymph node biopsy or pelvic lymph node dissection. Patients achieving optimal pathological response (defined as pathological complete response or residual tumor depth ≤3 mm) receive 2 additional cycles of the same regimen followed by QL1706 maintenance therapy for 8 cycles. Non-optimal responders receive adjuvant therapy per NCCN guidelines. Patients who cannot tolerate surgery or have contraindications receive radical radiotherapy.

Sample Size Justification and Statistical Framework The sample size was calculated using Simon's two-stage optimal design (one-sided alpha=0.05, power=80%; null hypothesis pCR=30% vs. alternative pCR=43%). The first stage enrolls 33 patients; if 10 or more pCR events are observed, enrollment continues to a total of 94 evaluable patients. Accounting for 10% dropout, total target enrollment is 103 patients.

Data and Safety Monitoring An independent Data Monitoring Committee will oversee patient safety and conduct periodic reviews. The Committee may recommend early termination for efficacy, futility, or safety concerns. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, with written informed consent obtained from all participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Jihong Liu, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 to 70 years.
  2. Histologically or cytologically confirmed cervical cancer, FIGO stage IB3 or IIA2.
  3. Imaging findings showing pelvic lymph node short-axis diameter < 1.5 cm and para-aortic lymph node short-axis diameter < 1.5 cm.
  4. Pathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
  5. No prior anti-tumor therapy.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

  1. Presence of other concurrent malignancies.
  2. Pregnant or peripartum women.
  3. History of myocardial infarction or stroke, unstable angina, decompensated heart failure, or deep vein thrombosis.
  4. Presence of NCI-CTCAE version 5.0 grade ≥2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
  5. Active unresolved hepatitis, defined as progressive decrease in appetite, general weakness, nausea, acid reflux, aversion to oily foods, abdominal distension, or abnormal liver function with jaundice (e.g., scleral or urinary jaundice); for hepatitis B, HBV DNA > 1000 IU/mL.
  6. Hepatic insufficiency (aspartate aminotransferase/alanine aminotransferase > 2.5 × upper limit of normal).
  7. Renal insufficiency (serum creatinine > 2 × upper limit of normal).
  8. History of chronic pulmonary disease with restrictive respiratory dysfunction.
  9. History of major organ transplantation or autoimmune disease.
  10. History of severe mental illness or cerebral dysfunction.
  11. History of substance abuse or drug addiction.
  12. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (dose > 10 mg prednisone or equivalent) within 2 weeks prior to enrollment, with ongoing use.
  13. Coagulation abnormality (INR > 2.0, PT > 16 seconds), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy (prophylactic low-dose aspirin and low-molecular-weight heparin are permitted).
  14. Congenital or acquired immunodeficiency (e.g., HIV infection).
  15. Receipt of inactivated vaccine within 30 days prior to the first dose of study treatment.
  16. Inability or unwillingness to provide written informed consent or comply with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: QL1706 + TP/TC Neoadjuvant Chemoimmunotherapy
Participants receive up to 4 cycles of neoadjuvant therapy (once every 3 weeks) with iparomlimab and tuvonralimab (QL1706 250 mg, IV) plus paclitaxel (150-175 mg/m², IV) and either cisplatin (70-75 mg/m², IV, split over 2 days) or carboplatin (AUC=5, IV). Treatment response is assessed after 2 cycles. For patients achieving tumor shrinkage, neoadjuvant therapy continues for 2 additional cycles followed by imaging. Patients achieving complete response (CR) undergo cervical conization plus sentinel lymph node biopsy (SLNB) or pelvic lymph node dissection (PLND). Those achieving partial response (PR) or non-optimal pathological response after surgery undergo radical hysterectomy/trachelectomy plus SLNB/PLND. Participants who achieve optimal pathological response (pCR or residual tumor depth ≤3 mm) after surgery receive QL1706 maintenance therapy for up to 8 cycles (once every 3 weeks). Patients who cannot tolerate surgery or have contraindications undergo radical radiotherapy.
Drug: Iparomlimab and Tuvonralimab (QL1706)
250 mg administered intravenously over at least 30 minutes on Day 1 of each 21-day cycle for up to 4 cycles as neoadjuvant therapy, and up to 8 cycles as maintenance therapy (for patients achieving optimal pathological response).
Drug: Paclitaxel
150-175 mg/m² administered intravenously over at least 3 hours on Day 1 of each 21-day cycle for up to 4 cycles, with standard premedication to prevent hypersensitivity.
Drug: Cisplatin

70-75 mg/m² administered intravenously over at least 1 hour, split over two consecutive days (Day 1 and Day 2) of each 21-day cycle for up to 4 cycles.

Cisplatin or Carboplatin according to investigator's choice

Drug: Carboplatin

AUC=5 administered intravenously over at least 1 hour on Day 1 of each 21-day cycle for up to 4 cycles.

Cisplatin or Carboplatin according to investigator's choice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) Rate
Time Frame: At the time of surgery, following completion of neoadjuvant treatment (each cycle is 21 days; patients receive 2 to 4 cycles)
Proportion of patients with no residual invasive tumor cells in the surgically resected primary tumor specimen following neoadjuvant therapy.
At the time of surgery, following completion of neoadjuvant treatment (each cycle is 21 days; patients receive 2 to 4 cycles)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Pathological Response (MPR) Rate
Time Frame: At the time of surgery, following completion of neoadjuvant treatment (each cycle is 21 days)
Proportion of patients with residual tumor depth ≤3 mm in the surgically resected primary tumor specimen following neoadjuvant therapy.
At the time of surgery, following completion of neoadjuvant treatment (each cycle is 21 days)
Objective Response Rate (ORR)
Time Frame: After 4 cycles of neoadjuvant treatment (each cycle is 21 days)
Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria on imaging after neoadjuvant therapy.
After 4 cycles of neoadjuvant treatment (each cycle is 21 days)
3-Year Overall Survival (OS) Rate
Time Frame: From date of first dose to date of death from any cause, assessed up to 36 months
Overall survival rate at 3 years from study enrollment.
From date of first dose to date of death from any cause, assessed up to 36 months
3-Year Disease-Free Survival (DFS) Rate
Time Frame: From date of surgery to date of recurrence or death, assessed up to 36 months
Disease-free survival rate at 3 years from study enrollment.
From date of surgery to date of recurrence or death, assessed up to 36 months
Treatment-Related Adverse Events (TRAEs)
Time Frame: From first dose of study treatment until 90 days after last dose (each cycle is 21 days; up to 6 neoadjuvant cycles + up to 8 maintenance cycles; total up to approximately 12 months).
Incidence, grade, and relationship of adverse events (both conventional and immune-related TRAEs) assessed by NCI-CTCAE v5.0.
From first dose of study treatment until 90 days after last dose (each cycle is 21 days; up to 6 neoadjuvant cycles + up to 8 maintenance cycles; total up to approximately 12 months).
Patient-Reported Outcomes (PROs)-Change in Quality of Life as Measured by the EORTC QLQ-C30
Time Frame: Baseline (pre-treatment), and at 3, 6, 12, 24, and 36 months post-treatment. For assessments occurring during the treatment phase (each cycle is 21 days; up to 6 neoadjuvant cycles followed by up to 8 maintenance cycles).
Change from baseline in global health status/quality of life and functional/symptom scores measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). All scales range from 0 to 100. For the global health status and functional subscales, higher scores mean a better outcome. For the symptom subscales, higher scores mean a worse outcome.
Baseline (pre-treatment), and at 3, 6, 12, 24, and 36 months post-treatment. For assessments occurring during the treatment phase (each cycle is 21 days; up to 6 neoadjuvant cycles followed by up to 8 maintenance cycles).
Patient-Reported Outcomes (PROs)-Change in Cervical Cancer-Specific Symptoms as Measured by the EORTC QLQ-CX24
Time Frame: Baseline (pre-treatment), and at 3, 6, 12, 24, and 36 months post-treatment. For assessments occurring during the treatment phase (each cycle is 21 days; up to 6 neoadjuvant cycles followed by up to 8 maintenance cycles).
Change from baseline in symptom and functional scores measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cervical Cancer Module 24 (EORTC QLQ-CX24). All scales range from 0 to 100. For functional scales (including sexual activity), higher scores mean a better outcome. For symptom scales (including pain, lymphoedema, peripheral neuropathy, menopausal symptoms, and sexual worry), higher scores mean a worse outcome.
Baseline (pre-treatment), and at 3, 6, 12, 24, and 36 months post-treatment. For assessments occurring during the treatment phase (each cycle is 21 days; up to 6 neoadjuvant cycles followed by up to 8 maintenance cycles).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Predictive Biomarkers of Response
Time Frame: Baseline and at time of surgery
Association of treatment response with baseline and post-treatment biomarkers including PD-L1 expression, tumor mutation burden (TMB), tertiary lymphoid structures (TLS), and imaging features (radiomics).
Baseline and at time of surgery
Changes in Ovarian Function in Younger Patients
Time Frame: Baseline and within 1 month after surgery
Comparison of ovarian function (e.g., anti-Müllerian hormone, follicle-stimulating hormone, estradiol levels) before and after neoadjuvant treatment in premenopausal patients.
Baseline and within 1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2026-154-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

"The informed consent form approved by the ethics committee does not include provisions for sharing individual participant data with external researchers. Therefore, IPD will not be shared."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Cervical Neoplasms

Clinical Trials on Iparomlimab and Tuvonralimab (QL1706)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings