Esophageal Squamous Cell Carcinoma (ESCC)Phase 3NCT07463573
QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 3 study testing QLC5508 and Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride) in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- QLC5508 and Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 5 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: 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).
- Being tested
- QLC5508, Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride)
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLC5508Drug
QLC5508 Injection
Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride)Drug
Investigator's Choice of Chemotherapy (ICC) (docetaxel, paclitaxel, or Irinotecan Hydrochloride)
| Study group | Role | What they receive |
|---|---|---|
| QLC5508 group | Experimental | Not described Receives: Drug: QLC5508 |
| Control group | Active comparator | Not described Receives: Drug: Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: From baseline to approximately Month 40
Secondary outcomes (6)
Progression-free survival (PFS)
Measured: From baseline to approximately Month 40
Objective Response Rate (ORR)
Measured: From baseline to approximately Month 40
Duration of Response (DOR)
Measured: From baseline to approximately Month 40
Disease Control Rate (DCR)
Measured: From baseline to approximately Month 40
Incidence of treatment-emergent adverse events
Measured: 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
Measured: From the time of the first dose of study drug to 28 days after the last dose of study drug is administered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start20 Apr 2026
- Primary completion5 Jun 2028 (estimated)
- Study completion5 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463573
- Sponsor's protocol ID
- QLC5508-303
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07463573
- Acronym / sponsor ID
- QLC5508-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 5 Jun 2028 (estimated)
- Study completion
- 5 Jul 2029 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLC5508 group | Experimental | Drug: QLC5508 |
| Control group | Active comparator | Drug: Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (29 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLC5508QLC5508 Injection | Drug | QLC5508 group |
| Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride)Investigator's Choice of Chemotherapy (ICC) (docetaxel, paclitaxel, or Irinotecan Hydrochloride) | Drug | Control group |
Primary outcome
Overall Survival (OS)
Time frame: From baseline to approximately Month 40
6 secondary outcomes
Progression-free survival (PFS)
Time frame: From baseline to approximately Month 40
Objective Response Rate (ORR)
Time frame: From baseline to approximately Month 40
Duration of Response (DOR)
Time frame: From baseline to approximately Month 40
Disease Control Rate (DCR)
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QLC5508 and Investigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride) in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, B.M. (+86010-88196561, doctorshenlin@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From baseline to approximately Month 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.