Health TrialsbyHealthPanel

Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma

ConditionEsophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab govitecan

    Drug

    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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Sacituzumab govitecanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
18 weeks

Secondary outcomes

1

Overall survival (OS)

The time from enrollment to death of any cause or the last follow-up (censored).

Time frame
1 year
2

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.

Time frame
6 months
3

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).

Time frame
6 months
4

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Toxicities per CTCAE 5.0

Time frame
6 months

Other outcomes

1

Biomarkers-related endpoints

ORR by RECIST 1.1 according to immunohistochemistry-(IHC)-detected Trop-2 expression levels.

Time frame
18 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Gilead Sciences

Collaborator

Source ClinicalTrials.gov
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