Health TrialsbyHealthPanel

Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

ConditionsEsophageal Squamous Cell CarcinomaNeoadjuvant Therapies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLi Zhang

About this trial

The goal of this trial is to test the efficacy and safety of cardenilimab combined with chemotherapy in the conversion therapy of locally advanced unresectable esophageal squamous cell carcinoma.

type of study: clinical trial

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor in the past 14 days;

Without blood transfusion in the past 14 days, platelets ≥100×109/L;

Hemoglobin >9g/dL without blood transfusion or erythropoietin use in the past 14 days;

Total bilirubin ≤1.5×upper limit of normal (ULN);

Disqualifiers

Other malignant diseases diagnosed within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has been radically resected);

Endoscopically known signs of active bleeding in the lesion;

Currently participating in interventional clinical research treatment, or have received other research drugs or used research equipment within 4 weeks before the first dose;

Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another type of stimulating or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137 etc.) drugs;

Trial design

Design model

Single group

Treatments tested in this trial

  • Cardenilimab Combined With Chemotherapy

    Drug

    Cardenilimab Combined With Chemotherapy

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: Cardenilimab Combined With ChemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

The time from randomization to death from any cause.

Time frame
2-5 years

Secondary outcomes

1

Pathologic Complete Response

According to the detection of pathological specimens after operation, no malignant tumor cells were detected, so the patient achieved complete pathological remission.

Time frame
2-5 years
2

Progression-Free-Survival

The time between the beginning of treatment and the observation of disease

Time frame
2-5 years
3

Overall survival

The time from randomization to death from any cause.

Time frame
2-5 years
4

Safety

The safety of drugs was evaluated from four aspects: adverse events, adverse reactions, serious adverse events and serious adverse reactions.

Time frame
2-5 years

Other outcomes

Sponsors and contacts

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

Li Zhang

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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