Health TrialsbyHealthPanel

Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC

ConditionLOCALLY ADVANCED CERVICAL CANCERS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This study is a clinical study to evaluate the safety and efficacy of Iparomlimab/Tuvonralimab Injection (QL1706, a Bifunctional Mabpair Product of Anti-PD-1 and Anti-CTLA-4 Antibodies) in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent.

Female patients aged ≥18 years and ≤ 75 years at time of inform consent signature

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Expected survival ≥ 3 months

Disqualifiers

Cervical cancer of other histology (e.g., neuroendocrine carcinoma, sarcoma)

Evidence of distant metastasis

Prior total hysterectomy (subtotal or cervical-sparing surgery allowed)

Unable or unwilling to receive brachytherapy

Trial design

Design model

Single group

Treatments tested in this trial

  • Iparomlimab/Tuvonralimab

    Drug

    IV infusion

  • Cisplatin

    Drug

    IV infusion

  • Brachytherapy and External Beam Radiotherapy

    Radiation

    Radiation

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 3 interventions
Group B: Arm 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

2-year PFS rate

Time frame
up to 24 months

Secondary outcomes

1

ORR

Time frame
Up to approximately 24 months
2

PFS

Time frame
Up to approximately 24 months
3

DCR

Time frame
Up to approximately 24 months
4

DoR

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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