Esophageal Squamous Cell CarcinomasPhase 2SINCERENCT05103501
Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy
A Phase 2 study testing PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab） in people with Esophageal Squamous Cell Carcinomas, run by Shanghai Chest Hospital.
Trial summary
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinomas
- What is being tested?
- PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 30 Sep 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Stage II/III carcinoma of the esophagus squamous cell carcinoma.
- Completed pre-operative chemoradiotherapy followed by surgery
- Diagnosed with residual pathologic disease after being surgically rendered free of
- Disease with negative margins following complete resection
- Nonresponding to initial neoadjuvant Chemoradiotherapy(TRG3 and TRG4)
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, radiation pneumonitis 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；
- Has not fully recovered from toxicity and/or complications from any intervention prior to initiation of treatment (i.e., ≤ grade 1 or level required at baseline, excluding fatigue or hair loss);
- Allergic reactions to test drugs for this application；
- Pregnant or lactating women； Those whom the investigator considered unsuitable for inclusion。
About this study
Official title: Salvage Immunotherapy Combined With Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy (SINCERE Study)
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.
- Conditions
- Esophageal Squamous Cell Carcinomas
- Being tested
- PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab）Drug
immunotherapy:PD-1 inhibitor chemotherapy:5-Fu and DDP
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | PF regimen (cis-platinum of 75mg/m2/d, d1; 5-fluorouracil of 600mg/m2d1-4) combined with PD-1 inhibitors（pembrolizumab，200mg d1） every 3 weeks for 4 cycles followed by PD-1 inhibitors（pembrolizumab，200mg d1）every 3 weeks up to 2 years in a standard manner. Receives: Drug: PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS)
Disease-free survival is defined as the time between date of surgery and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events.
Measured: up to approximately 46 months
Secondary outcomes (2)
Overall survival (OS)
Overall survival is defined as the time from date of surgery to date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date").
Measured: up to approximately 46 months
Overall Survival Rate
Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following surgery
Measured: From date of surgery to 1, 2 and 3 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2024 (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 CarcinomasStudies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103501
- Sponsor's protocol ID
- JLiu
- Acronym
- SINCERE
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- 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 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Immunotherapy Combined With Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy (SINCERE Study)
- ClinicalTrials.gov ID
- NCT05103501
- Acronym / sponsor ID
- SINCERE / JLiu
- Conditions
- Esophageal Squamous Cell Carcinomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 2 Nov 2021 (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 esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab）PF regimen (cis-platinum of 75mg/m2/d, d1; 5-fluorouracil of 600mg/m2d1-4) combined with PD-1 inhibitors（pembrolizumab，200mg d1） every 3 weeks for 4 cycles followed by PD-1 inhibitors（pembrolizumab，200mg d1）every 3 weeks up to 2 years in a standard manner. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Stage II/III carcinoma of the esophagus squamous cell carcinoma.
- Completed pre-operative chemoradiotherapy followed by surgery
- Diagnosed with residual pathologic disease after being surgically rendered free of
- Disease with negative margins following complete resection
- Nonresponding to initial neoadjuvant Chemoradiotherapy(TRG3 and TRG4)
Key exclusion criteria (8 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, radiation pneumonitis 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；
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 |
|---|---|---|
| PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab）immunotherapy:PD-1 inhibitor chemotherapy:5-Fu and DDP | Drug | experimental arm |
Primary outcome
Disease-free Survival (DFS)
Time frame: up to approximately 46 months
Disease-free survival is defined as the time between date of surgery and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events.
2 secondary outcomes
Overall survival (OS)
Time frame: up to approximately 46 months
Overall Survival Rate
Time frame: From date of surgery to 1, 2 and 3 years later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab） in people with Esophageal Squamous Cell Carcinomas, run by Shanghai Chest Hospital.
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 5 inclusion and 8 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (DFS) (time frame: up to approximately 46 months). 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 2 Nov 2021.