QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy for Cervical Cancer

NCT07617818 | Not Yet Recruiting Phase 2

• 1 other identifier: CERVINA Study
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cervical Cancer; Neoadjuvant Therapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  Proportion of patients achieving pathological complete response after neoadjuvant therapy.

  At surgery following completion of neoadjuvant therapy

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  During neoadjuvant treatment period

• Progression-Free Survival (PFS)

  Up to 3 years

• 3-Year Pelvic Recurrence Rate

  3 years

• Adverse Events

  From informed consent through 30 days after last treatment dose

• Overall Survival (OS)

  Up to 3 years

Study Arms (1)

Experimental Arm

EXPERIMENTAL

QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy

Drug: QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy

Interventions

QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy DRUG

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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jianwei Zhou, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhigang Zhang, MD

CONTACT

86057189713631; zzg2011@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 1, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): December 15, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share