QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma

ConditionEsophageal Squamous Cell Carcinoma (ESCC)

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorQilu Pharmaceutical Co., Ltd.

About this trial

This study is designed to assess the efficacy and safety of QLC5508 in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily consent to participate in this study and sign the informed consent form.

Males and females aged ≥18 years old;

Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 within 7 days before the first dose;

Estimated survival time of more than 3 months.

Disqualifiers

Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.

Having histologically or cytologically confirmed adenosquamous carcinoma subtype.

Brain metastases (unless asymptomatic and no progression confirmed by imaging ≥4 weeks prior to randomization);

Presence of leptomeningeal metastases or brainstem metastases;

Trial design

Design model

Parallel

Treatments tested in this trial

QLC5508
Drug
QLC5508 Injection
Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride)
Drug
Investigator's Choice of Chemotherapy (ICC) (docetaxel, paclitaxel, or Irinotecan Hydrochloride)

Treatment groups

466 Participants

are divided into 2 treatment groups

Group A: QLC5508 groupExperimental treatment 1 intervention

Group B: Control groupActive comparator 1 intervention