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)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Zhigang Zhang, MD
- Telefoonnummer: 86057189713631
- E-mail: zzg2011@zju.edu.cn
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Experimental Arm
QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pathological Complete Response (pCR)
Tijdsspanne: At surgery following completion of neoadjuvant therapy
|
Proportion of patients achieving pathological complete response after neoadjuvant therapy.
|
At surgery following completion of neoadjuvant therapy
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Objective Response Rate (ORR)
Tijdsspanne: During neoadjuvant treatment period
|
Proportion of patients achieving complete or partial response according to RECIST v1.1.
|
During neoadjuvant treatment period
|
|
Progression-Free Survival (PFS)
Tijdsspanne: Up to 3 years
|
Time from treatment initiation to disease progression or death.
|
Up to 3 years
|
|
3-Year Pelvic Recurrence Rate
Tijdsspanne: 3 years
|
Proportion of patients with pelvic recurrence within 3 years.
|
3 years
|
|
Adverse Events
Tijdsspanne: From informed consent through 30 days after last treatment dose
|
Incidence and severity of adverse events graded according to CTCAE v5.0.
|
From informed consent through 30 days after last treatment dose
|
|
Overall Survival (OS)
Tijdsspanne: Up to 3 years
|
Time from treatment initiation to death from any cause
|
Up to 3 years
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jianwei Zhou, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Genitale ziekten
- Urogenitale neoplasmata
- Neoplasmata per site
- Neoplasmata
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Baarmoeder Ziekten
- Genitale ziekten, vrouw
- Genitale neoplasmata, vrouwelijk
- Baarmoederhalsaandoeningen
- Baarmoeder Neoplasmata
- Baarmoeder Cervicale Neoplasmata
- Anorganische chemicaliën
- Chloorverbindingen
- Stikstofverbindingen
- Platinumverbindingen
- Cisplatine
Andere studie-ID-nummers
- CERVINA Study
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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