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

April 21, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

A Randomized, Open-Label, Multicenter Phase III Study of QLC5508 Versus Investigator's Choice Chemotherapy in Pretreated Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

466

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Peking University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • A serum pregnancy test must be performed within 7 days prior to randomization for premenopausal women of childbearing potential, and the result must be negative and must not be lactating;
  • All enrolled patients and the partners should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
  • Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures.
  • Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0 (v6.0);

  • Has histologically or cytologically documented unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) according to American Joint Committee on Cancer 8th edition staging system on ESCC.

    • Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as assessed by the investigator.
  • Sufficient bone marrow and organ function.

Exclusion Criteria:

  • 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;
  • Spinal cord compression (identified via imaging, regardless of symptoms);
  • Previous or ongoing treatment with topoisomerase I inhibitors
  • Having previously received B7-H3-targeted therapy.
  • Being ineligible to any chemotherapies in the control arm due to prior progression or intolerance.
  • Insufficient washout of prior anticancer therapies prior to randomization.
  • Having underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to randomization;
  • Requiring elective surgery during the study.
  • Having received live vaccine or live attenuated vaccine within 4 weeks before study randomization.
  • Having received treatment with systemic corticosteroids (prednisone at >10 mg/day, or similar drugs at equivalent dose) or other immunosuppressive agents within 14 days prior to randomization;
  • Moderate to severe pulmonary disease significantly impairing lung function, including idiopathic pulmonary fibrosis, autoimmune/connective tissue disorders with lung involvement, or prior pneumonectomy.
  • Having a history of interstitial lung disease (ILD)/ non-infectious pneumonitis that required corticosteroids, current ILD/ non-infectious pneumonitis, or suspected ILD/ non-infectious pneumonitis that cannot be ruled out by imaging at screening;
  • Active tuberculosis;
  • Autoimmune diseases not in clinical remission, other acquired or congenital immunodeficiency diseases,
  • A history of allogeneic stem cell, bone marrow, or organ transplantation.
  • Serious infections (e.g., bacteremia, or severe pneumonia) within 4 weeks prior to randomization;
  • active infection requiring systemic antibiotic therapy within 1 weeks prior to randomization;
  • Has positive results in virus serology tests (hepatitis B virus infection participants receiving antiviral treatment other than interferon are allowed to be enrolled);
  • Uncontrolled or significant cardiovascular disease.
  • Clinically uncontrolled third-space effusion.
  • Known hypersensitivity to investigational product components, analogues, or control drugs (e.g., docetaxel, paclitaxel, irinotecan hydrochloride).
  • Drug abuse;
  • Any other medical conditions that may interfere with study participation or the results of the clinical study as per the discretion of investigator;
  • Has alcohol or drug dependence.
  • Poor compliance as per investigator discretion;
  • Has a history of other serious systemic diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Drug: Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride)
Investigator's Choice of Chemotherapy (ICC) (docetaxel, paclitaxel, or Irinotecan Hydrochloride)
Experimental: QLC5508 group
Drug: QLC5508
QLC5508 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From baseline to approximately Month 40
From baseline to approximately Month 40

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: From baseline to approximately Month 40
From baseline to approximately Month 40
Objective Response Rate (ORR)
Time Frame: From baseline to approximately Month 40
From baseline to approximately Month 40
Duration of Response (DOR)
Time Frame: From baseline to approximately Month 40
From baseline to approximately Month 40
Disease Control Rate (DCR)
Time Frame: From baseline to approximately Month 40
From baseline to approximately Month 40
Incidence of treatment-emergent adverse events
Time Frame: From the time of the first dose of study drug to 28 days after the last dose of study drug is administered.
From the time of the first dose of study drug to 28 days after the last dose of study drug is administered.
Severity of treatment-emergent adverse events
Time Frame: From the time of the first dose of study drug to 28 days after the last dose of study drug is administered.
From the time of the first dose of study drug to 28 days after the last dose of study drug is administered.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

June 5, 2028

Study Completion (Estimated)

July 5, 2029

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLC5508-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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