Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

Esophageal squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. The rate of pCR under ICIs combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pCR in reality. In order to explore a more effective mode of neoadjuvant therapy for ESCC, we designed this study to evaluate the effect of PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced ESCC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosed with esophageal squamous cell cancer;

staged with cT1N+M0/cT2-3N0-3M0;

experienced no cancer-related treatment;

ECOG 0-1;

Disqualifiers

diagnosed with other types of cancer during last five years;

have a tendency to bleed;

accepted any type of cancer-related therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • cadonilizumab combined with neoadjuvant radiochemotherapy

    Combination product

    Subjects randomized to experimental arm will be treated with PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy before surgery.

  • neoadjuvant radiochemotherapy

    Combination product

    Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy.

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Arm 1: cadonilizumab combined with neoadjuvant radiochemotherapyExperimental treatment 1 intervention
Group B: Arm 2: neoadjuvant radiochemotherapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

pCR

pathological complete response

Time frame
perioperative

Secondary outcomes

Other outcomes

Sponsors and contacts

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