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

26. maj 2026 opdateret af: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental Arm
QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pathological Complete Response (pCR)
Tidsramme: At surgery following completion of neoadjuvant therapy
Proportion of patients achieving pathological complete response after neoadjuvant therapy.
At surgery following completion of neoadjuvant therapy

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: 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)
Tidsramme: Up to 3 years
Time from treatment initiation to disease progression or death.
Up to 3 years
3-Year Pelvic Recurrence Rate
Tidsramme: 3 years
Proportion of patients with pelvic recurrence within 3 years.
3 years
Adverse Events
Tidsramme: 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)
Tidsramme: Up to 3 years
Time from treatment initiation to death from any cause
Up to 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Efterforskere

  • Ledende efterforsker: Jianwei Zhou, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

15. juni 2028

Studieafslutning (Anslået)

15. december 2029

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CERVINA Study

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Livmoderhalskræft

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