Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Immunotherapy | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy
- interventionNames
- Drug: QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR)
- timeFrame
- At surgery following completion of neoadjuvant therapy
- description
- Proportion of patients achieving pathological complete response after neoadjuvant therapy.
Secondary outcomes (5)
- measure
- Objective Response Rate (ORR)
- timeFrame
- During neoadjuvant treatment period
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available