QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma
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
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
Treatments tested in this trial
- QLC5508
- Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride)
Treatment groups
466 Participants
are divided into 2 treatment groupsLocations
1Peking University Cancer Hospital100142, BeijingBeijing Municipality, China
Sponsors and collaborators
Qilu Pharmaceutical Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov