Metastatic Esophageal Squamous Cell CarcinomaPhase 2/3NCT06138028
Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer
A Phase 2/3 study testing TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab） in people with Metastatic Esophageal Squamous Cell Carcinoma, run by Qingdao Central Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Esophageal Squamous Cell Carcinoma
- What is being tested?
- TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 20 Sep 2023to 31 Oct 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Organ function levels must meet the following requirements and meet the following standards:
- 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;
Who cannot join
- 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；
- Allergic reactions to test drugs for this application；
- Pregnant or lactating women； Those whom the investigator considered unsuitable for inclusion。
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, 266042
youxin ji, M.D., 8653268665078, mdji001@gmail.com
ketao lan, M.D.
- Recruiting
Qingdao Central Hospital
Qingdao, Shandong, 266042
KEKE NIE, MD, 68665078, NIEKEKEQD@163.COM
About this study
Official title: The Prospective Study of Sintilimab Combination With Chemotherapy Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma
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.
- Being tested
- TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）
- 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined chemo-immuno-irradiation | Experimental | TP regimen plus PD-1 inhibitor for 4 cycles then irradiation and PD-1 inhibitor maintenance therapy for 13 cycles. Receives: Drug: TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
time from enrollment to patients death
Measured: up to 24 months
Progression-free survival (PFS)
time from disease progression or patient death
Measured: up to 12 months
Secondary outcomes (2)
overall response rate (ORR)
complete response plus partial response
Measured: up to 12 weeks
toxicities
toxicities according to CTCAE 5.0
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Sep 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138028
- Sponsor's protocol ID
- KY202306702
- Status last verified
- Jul 2024
- First submitted
- 8 Nov 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Study of Sintilimab Combination With Chemotherapy Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06138028
- Acronym / sponsor ID
- KY202306702
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Nov 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined chemo-immuno-irradiation | Experimental | Drug: TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）TP regimen plus PD-1 inhibitor for 4 cycles then irradiation and PD-1 inhibitor maintenance therapy for 13 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Organ function levels must meet the following requirements and meet the following standards:
Key exclusion criteria (6 listed)
- 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；
- Allergic reactions to test drugs for this application；
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 |
|---|---|---|
| TP 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. | Drug | Combined chemo-immuno-irradiation |
Primary outcome
Overall survival (OS)
Time frame: up to 24 months
time from enrollment to patients death
Progression-free survival (PFS)
Time frame: up to 12 months
time from disease progression or patient death
2 secondary outcomes
overall response rate (ORR)
Time frame: up to 12 weeks
toxicities
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab） in people with Metastatic Esophageal Squamous Cell Carcinoma, run by Qingdao Central Hospital at 2 sites 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 24 months). The study lists 2 primary outcomes in all. 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 Jul 2024.