Esophageal Squamous Cell CarcinomaPhase 2SG-ESCCNCT06329869
Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Sacituzumab govitecan in people with Esophageal Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Sacituzumab govitecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to Nov 2027
- Phase
- Phase 2
- 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
- Female or male patients, 18 years of age or older, able to understand and give written informed consent.
- Histologically proven squamous cell carcinoma of esophagus.
- Patients with advanced ESCC, defined as those with unresectable locally advanced, recurrent, or metastatic disease, failed prior platinum-based chemotherapy and anti-PD-1/PD-L1 therapy (adjuvant anti-PD-1 therapy considered as prior exposure of anti-PD-1/PD-L1 therapy; progression or recurrence within 6 months of platinum-based chemoradiotherapy for localized disease considered as failed prior platinum-based chemotherapy).
- Measurable disease as determined by RECIST 1.1. Lesions in previously irradiated areas should not be considered measurable unless they have progressed since the radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Archival tumor tissue for Trop-2 expression and optional fresh biopsy if feasible.
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- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, ANC ≥ 1500/mm3, and platelets ≥ 100,000/µL).
- Adequate hepatic function (bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases, and serum albumin > 3 g/dL).
- Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976}.
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendices.
- Willing and able to comply with the requirements and restrictions in this protocol.
Who cannot join
- Positive serum pregnancy test or women who are breastfeeding.
- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
- Requirement for ongoing therapy with or prior use of any prohibited medications.
- Have had a prior anticancer biologic agent within 4 weeks prior to enrollment or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry.
- Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent. Patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study. If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Have previously received topoisomerase 1 inhibitors.
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- Have an active second malignancy. Patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed.
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.
- Have active serious infection requiring antibiotics.
- Have known history of HIV-1 or 2 (or positive HIV-1/2 antibody, if done at screening) with detectable viral load or taking medications that may interfere with SN-38 metabolism.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
- Patients who test positive for hepatitis B surface antigen (HBsAg) will not be eligible. Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.
- Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease.
- Patients who test positive for HIV antibody.
- Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
- Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study.
- Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.
- No adequate archival or fresh ESCC tumor tissues for characterization of Trop-2 expression.
- Active central nervous system metastases.
- Adenocarcinoma of esophagus or gastroesophageal junction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chih-Hung Hsu
About this study
Official title: A Phase II Study of Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma Patients
The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma.
Read the detailed description
Overexpression of Trop-2 was detected in ESCC compared with esophageal dysplasia. The investigators hypothesize that sacituzumab govitecan, by targeting Trop-2 which has been reported to be overexpressed in esophageal squamous cell carcinoma tumors, should have significant clinical activity in patients with advanced esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Sacituzumab govitecan
- Keywords
- sacituzumab govitecan, Trop-2
- 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.
Sacituzumab govitecanDrug
Sacituzumab govitecan, 10 mg/kg intravenous infusion (the first infusion is to be administered over 3 hours; subsequent infusions may be administered over 1 to 2 hours if previous infusions were well tolerated) on day 1 and 8 of 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab govitecan | Experimental | Not described Receives: Drug: Sacituzumab govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall objective response rates (ORR)
The proportion of patients whose tumor response is categorized as complete response (CR) and partial response (PR) according to RECIST 1.1.
Measured: 18 weeks
Secondary outcomes (4)
Overall survival (OS)
The time from enrollment to death of any cause or the last follow-up (censored).
Measured: 1 year
Progression-free survival (PFS)
The time from enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) and will be conducted in the whole study population.
Measured: 6 months
Duration of response (DOR)
The time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).
Measured: 6 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Toxicities per CTCAE 5.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Aug 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Chih-Hung Hsu, M.D., Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329869
- Sponsor's protocol ID
- 202401158MIFD
- Acronym
- SG-ESCC
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma Patients
- ClinicalTrials.gov ID
- NCT06329869
- Acronym / sponsor ID
- SG-ESCC / 202401158MIFD
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- sacituzumab govitecan, Trop-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 26 Mar 2024 (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.
The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma.
Detailed description
Overexpression of Trop-2 was detected in ESCC compared with esophageal dysplasia. The investigators hypothesize that sacituzumab govitecan, by targeting Trop-2 which has been reported to be overexpressed in esophageal squamous cell carcinoma tumors, should have significant clinical activity in patients with advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab govitecan | Experimental | Drug: Sacituzumab govitecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female or male patients, 18 years of age or older, able to understand and give written informed consent.
- Histologically proven squamous cell carcinoma of esophagus.
- Patients with advanced ESCC, defined as those with unresectable locally advanced, recurrent, or metastatic disease, failed prior platinum-based chemotherapy and anti-PD-1/PD-L1 therapy (adjuvant anti-PD-1 therapy considered as prior exposure of anti-PD-1/PD-L1 therapy; progression or recurrence within 6 months of platinum-based chemoradiotherapy for localized disease considered as failed prior platinum-based chemotherapy).
- Measurable disease as determined by RECIST 1.1. Lesions in previously irradiated areas should not be considered measurable unless they have progressed since the radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Key exclusion criteria (20 listed)
- Positive serum pregnancy test or women who are breastfeeding.
- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
- Requirement for ongoing therapy with or prior use of any prohibited medications.
- Have had a prior anticancer biologic agent within 4 weeks prior to enrollment or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry.
- Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent. Patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study. If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
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 |
|---|---|---|
| Sacituzumab govitecanSacituzumab govitecan, 10 mg/kg intravenous infusion (the first infusion is to be administered over 3 hours; subsequent infusions may be administered over 1 to 2 hours if previous infusions were well tolerated) on day 1 and 8 of 21-day cycle. | Drug | Sacituzumab govitecan |
Primary outcome
Overall objective response rates (ORR)
Time frame: 18 weeks
The proportion of patients whose tumor response is categorized as complete response (CR) and partial response (PR) according to RECIST 1.1.
4 secondary outcomes
Overall survival (OS)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 6 months
Duration of response (DOR)
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 6 months
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 21 Sep 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.
Chih-Hung Hsu, M.D., Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab govitecan in people with Esophageal Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
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 20 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 21 Sep 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chih-Hung Hsu, M.D., Ph.D. (886-2-2312-3456, chihhunghsu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall objective response rates (ORR) (time frame: 18 weeks). 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 21 Sep 2026.