Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQingdao Central Hospital

About this trial

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of treatment naive advanced esophageal squamous cell carcinoma patients. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with Stage IV esophagus squamous cell carcinoma.

Expected survival time ≥3 months

Enrolled patients must have at least one measurable lesion conforming to the RECIST V1.1 definition.

Physical fitness ECOG score of 0 or 1

Disqualifiers

Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)

Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation;Interstitial lung disease, drug-induced pneumonia,requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction;

There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia;

Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above;

Trial design

Design model

Single group

Treatments tested in this trial

  • TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)

    Drug

    TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)for 4 cycles, then irradiation of the residual lesions for 50Gy/2Gy/25f. After complete irradiation, sintilimab is administered every 21 days a cycle for additional 13 cycles.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Combined chemo-immuno-irradiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

time from enrollment to patients death

Time frame
up to 24 months
2

Progression-free survival (PFS)

time from disease progression or patient death

Time frame
up to 12 months

Secondary outcomes

1

overall response rate (ORR)

complete response plus partial response

Time frame
up to 12 weeks
2

toxicities

toxicities according to CTCAE 5.0

Time frame
up to 12 weeks

Other outcomes

Sponsors and contacts

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