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

NCT07463573 | Recruiting Phase 3

• 1 other identifier: QLC5508-303
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

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).

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  From baseline to approximately Month 40

Secondary Outcomes (6)

• Progression-free survival (PFS)

  From baseline to approximately Month 40

• Objective Response Rate (ORR)

  From baseline to approximately Month 40

• Duration of Response (DOR)

  From baseline to approximately Month 40

• Disease Control Rate (DCR)

  From baseline to approximately Month 40

• Incidence of treatment-emergent adverse events

  From the time of the first dose of study drug to 28 days after the last dose of study drug is administered.

Study Arms (2)

QLC5508 group

EXPERIMENTAL

Drug: QLC5508

Control group

ACTIVE COMPARATOR

Drug: Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride)

Interventions

QLC5508 DRUG

QLC5508 Injection

QLC5508 group

Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride) DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Docetaxel; Paclitaxel; Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Lin Shen, B.M.

CONTACT

+86010-88196561; doctorshenlin@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 11, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 5, 2028
• Study Completion (Estimated): July 5, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)