Actively Recruiting
QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-04-24
466
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily consent to participate and sign the informed consent form
- Male or female aged 18 years or older
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 within 7 days before first dose
- Estimated survival time longer than 3 months
- Negative serum pregnancy test within 7 days prior to randomization for premenopausal women of childbearing potential and not lactating
- Adequate barrier contraception during treatment and for 6 months after treatment end for patients and partners
- Able to understand and willing to comply with trial and follow-up procedures
- Toxicity from previous cancer treatments resolved to Grade 1 or less as defined by NCI-CTCAE version 6.0
- Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) per AJCC 8th edition
- At least one measurable lesion per RECIST version 1.1 as assessed by investigator
- Sufficient bone marrow and organ function
You will not qualify if you...
- Diagnosis of other primary cancers within 5 years before signing consent
- Histologically or cytologically confirmed adenosquamous carcinoma subtype
- Brain metastases unless asymptomatic and stable for at least 4 weeks before randomization
- Presence of leptomeningeal or brainstem metastases
- Spinal cord compression identified by imaging
- Previous or ongoing treatment with topoisomerase I inhibitors
- Prior treatment with B7-H3-targeted therapy
- Ineligibility for control arm chemotherapy due to prior progression or intolerance
- Insufficient washout from previous anticancer treatments before randomization
- Major organ surgery or significant trauma within 4 weeks prior to randomization
- Planned elective surgery during study
- Receipt of live or live attenuated vaccines within 4 weeks before randomization
- Treatment with systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive agents within 14 days prior to randomization
- Moderate to severe lung disease impairing lung function, including idiopathic pulmonary fibrosis, autoimmune/connective tissue lung involvement, or prior pneumonectomy
- History or current interstitial lung disease or non-infectious pneumonitis requiring corticosteroids, or suspected but unruled out by imaging
- Active tuberculosis
- Autoimmune diseases not in remission or acquired/congenital immunodeficiency
- History of stem cell, bone marrow, or organ transplant
- Serious infections within 4 weeks prior to randomization or active infection requiring antibiotics within 1 week
- Positive viral serology except treated hepatitis B virus infection
- Uncontrolled or significant heart disease
- Clinically uncontrolled third-space effusion
- Known allergy to study drugs or their components
- Drug abuse or dependence
- Other serious systemic diseases or poor compliance as judged by investigator
- Alcohol or drug dependence history
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Lin Shen, B.M.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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