NCT07617818Not yet recruitingPhase 2
QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy for Cervical Cancer
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)
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 26 May 2026
- Start date
- Jun 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Cervical cancer
- NCT number
- NCT07617818
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From Jun 2026 to the primary completion date, Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of uncontrolled concomitant malignancies.
- Receipt of live vaccines within 30 days before first dose.
Other illness
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.