NCT07463573 QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma
| NCT ID | NCT07463573 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Esophageal Squamous Cell Carcinoma (ESCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 466 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2028-06-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 466 participants in total. It began in 2026-04-20 with a primary completion date of 2028-06-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07463573 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Squamous Cell Carcinoma (ESCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07463573 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 466 participants.
Is NCT07463573 currently recruiting?
Yes, NCT07463573 is actively recruiting participants. Contact the research team at doctorshenlin@sina.com for enrollment information.
Where is the NCT07463573 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07463573 clinical trial?
NCT07463573 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 466 participants.