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RecruitingNCT06138028Updated Jul 24, 2024

Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

A Phase 2/3 interventional study of TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab) in Metastatic Esophageal Squamous Cell Carcinoma, sponsored by Qingdao Central Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Qingdao Central Hospital · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Metastatic Esophageal Squamous Cell Carcinoma
03

In context

Esophageal Squamous Cell Carcinoma

657 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 276 are open to participants now.

This study's planned enrollment of 90 is above the median of 64 across 550 interventional studies indexed under Esophageal Squamous Cell Carcinoma.

Browse Esophageal Squamous Cell Carcinoma studies →

Lead sponsor

Qingdao Central Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosed with Stage IV esophagus squamous cell carcinoma.
  2. Expected survival time ≥3 months
  3. Enrolled patients must have at least one measurable lesion conforming to the RECIST V1.1 definition.
  4. Physical fitness ECOG score of 0 or 1
  5. Organ function levels must meet the following requirements and meet the following standards:

A) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ≥90×10\^9/L, hemoglobin ≥90 g/L; B) Liver function: Total bilirubin TBIL≤1.5×ULN (total bilirubin ≤3×ULN in Subjects with Gilbert's syndrome, liver cancer or liver metastasis), AST and ALT ≤2.5×ULN in patients without liver metastasis, AST and ALT ≤5.0×ULN in patients with liver metastasis; C) Renal function: Creatinine (Cr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula); D) Urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24 hours \< 1g can be included); E) Cardiac function: left ventricular ejection fraction ≥50%; F) Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN;

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. 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;
  3. 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;
  4. 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;
  5. Allergic reactions to test drugs for this application;
  6. Pregnant or lactating women; Those whom the investigator considered unsuitable for inclusion。
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Combined chemo-immuno-irradiation

    TP regimen plus PD-1 inhibitor for 4 cycles then irradiation and PD-1 inhibitor maintenance therapy for 13 cycles.

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

Interventions

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

    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.

06

What researchers measure

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

07

Study locations

2 of 2 sites recruiting
  • Qingdao Central Hospital, Qingdao Cancer Hospital
    Qingdao, Shandong 266042, China
    • youxin ji, M.D. · Contact · mdji001@gmail.com · 8653268665078
    • ketao lan, M.D. · Principal investigator
    • chunling zhang, M.D. · Sub investigator
    • youxin ji, M.D. · Sub investigator
    Recruiting
  • Qingdao Central Hospital
    Qingdao, Shandong 266042, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Oct 2025, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2023
First posted
Nov 18, 2023
StartActual
Sep 20, 2023
Primary completionEst.
Oct 31, 2025
CompletionEst.
Oct 31, 2026
Last update
Jul 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06138028
Lead sponsor
Qingdao Central Hospital
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Sep 20, 2023
Primary completion
Oct 31, 2025 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Jul 24, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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