Esophageal Squamous Cell CarcinomaPhase 2NCT06190639
A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive ESCC
A Phase 2 study testing sintilimab in people with Esophageal Squamous Cell Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of sintilimab as adjuvant therapy in node-positive esophageal squamous cell carcinoma after radical surgery without neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed an Informed Consent Form
- Participant type and target disease characteristics:
- ECOG PS 0-1
- Histologically confirmed T1-3N+M0 thoracic esophageal squamous cell cancer (AJCC 8th)
- can tolerate radical resection of esophageal cancer
- Resection must be performed within 4-12 weeks prior to enrollment
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- All participants must be confirmed disease-free by physical and imaging examinations within 4 weeks prior to enrollment. Imaging examinations must include CT/MRI scans of the neck, chest and abdomen.
- All baseline laboratory tests will be evaluated as required and results should be available within 28 days prior to enrollment. Laboratory test values must be selected according to the following criteria (CTCAE V5.0):
- WBC ≥2000/μL;
- Neutrophils ≥1500/μL;
- Platelets ≥100 x 103/μL;
- Hemoglobin ≥9.0 g/dL;
- Creatinine: Serum creatinine ≤1.5 x above normal (ULN) or creatinine removal rate > 50mL/ min (Cockcroft/Gault formula);
- AST ≤3 x ULN;
- ALT ≤3 x ULN;
- Total bilirubin ≤1.5 x ULN (except for subjects with Gilbert syndrome, where total bilirubin must be < 3 x ULN);
- Age and fertility status:
- Age ≥18 years old
- Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity of HCG is 25 IU/L or equivalent) within 24 hours before starting study treatment.
- Women must be non-breastfeeding
Who cannot join
- Target disease
- The presence of locally advanced unresectable (regardless of stage) or metastatic disease.
- Cervical and abdominal esophageal tumors.
- Medical history and concurrent diseases
- Complete resection followed by treatment for the removed esophageal cancer (e.g., chemotherapy, targeted drugs, radiation, or biotherapy).
- Participants with ≥ grade 2 peripheral neuropathy
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- Participants with active, known, or suspected autoimmune diseases. Participants with type I diabetes, hypothyroidism requiring only hormone replacement therapy, skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur without external irritants, may be enrolled.
- Glucocorticoids are required for 14 days prior to treatment (daily>10 mg equivalent dose of prednisone) or other immunosuppressive drugs for systemic treatment.
- If there is no active autoimmune disease, inhaled or topical steroid hormones are permitted, and daily>10 mg prednisone equivalent dose of adrenal hormone replacement therapy.
- A known history of testing positive for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS)
- Participants with a serious or uncontrolled medical condition.
- Radiotherapy, chemotherapy, immunotherapy, esophagectomy, esophagus-gastric junction, and gastric surgery were performed before the trial.
- Participants with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a history of prior interstitial pneumonia.
- Active malignancy within the last 3 years, other than locally curable cancers that have apparently been cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Participants with a serious or uncontrolled medical condition
- Physical and laboratory examination
- Participants were found to have active hepatitis B (Hepatitis B surface antigen [HBsAg] positive or hepatitis C virus (HCV) positive (HCV RNA positive) Sex). Participants with prior HBV infection or recovered HBV infection (defined as having hepatitis B core antibodies [HBcAb] and no HBsAg) were eligible. HBV DNA must be obtained from these patients before treatment. Participants who are HBV carriers or require antiviral therapy are not eligible to participate. Participants who were positive for HCV antibodies were eligible only if the PCR for HCV RNA was negative.
- Allergies and adverse drug reactions
- History of allergy or hypersensitivity to study drug ingredients.
- A history of severe hypersensitivity to any monoclonal antibody.
- Other exclusion criteria
- Participants who do not understand or may not comply with the requirements of the trial
- Participants had an active infection requiring systemic treatment in the 28 days prior to first dosing
- Some obvious diseases that the researchers believe should be excluded from this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Changchun Wang, MD
About this study
Official title: A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive Esophageal Squamous Cell Carcinoma After Radical Surgery Without Neoadjuvant Therapy
The goal of this clinical trial is to evaluate the efficacy and safety of sintilimab as adjuvant therapy in node-positive esophageal squamous cell carcinoma after radical surgery without neoadjuvant therapy. The main question it aims to answer is:
- Efficacy of sintilimab as adjuvant therapy Participants will receive sintilimab 200 mg once on day 1, every 21 days(Q3W).
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- 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.
sintilimabDrug
200 mg once on day 1, every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
From date of randomization until the date of first documented progression
Measured: assessed up to 36months
Secondary outcomes (1)
Overall survival (OS)
From date of randomization until the date of death from any cause
Measured: assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start25 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changchun Wang, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190639
- Sponsor's protocol ID
- IRB-2023-768
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive Esophageal Squamous Cell Carcinoma After Radical Surgery Without Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT06190639
- Acronym / sponsor ID
- IRB-2023-768
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jan 2024 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of sintilimab as adjuvant therapy in node-positive esophageal squamous cell carcinoma after radical surgery without neoadjuvant therapy. The main question it aims to answer is:
- Efficacy of sintilimab as adjuvant therapy Participants will receive sintilimab 200 mg once on day 1, every 21 days(Q3W).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: sintilimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed an Informed Consent Form
- Participant type and target disease characteristics:
- Age and fertility status:
Key exclusion criteria (24 listed)
- Target disease
- Medical history and concurrent diseases
- If there is no active autoimmune disease, inhaled or topical steroid hormones are permitted, and daily>10 mg prednisone equivalent dose of adrenal hormone replacement therapy.
- Physical and laboratory examination
- Allergies and adverse drug reactions
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 |
|---|---|---|
| sintilimab200 mg once on day 1, every 21 days | Drug | Experimental group |
Primary outcome
Disease-free survival (DFS)
Time frame: assessed up to 36months
From date of randomization until the date of first documented progression
1 secondary outcome
Overall survival (OS)
Time frame: assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sintilimab in people with Esophageal Squamous Cell Carcinoma, run by Zhejiang Cancer Hospital at 1 site 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 20 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changchun Wang, MD (13606520363, wangcc@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: assessed up to 36months). 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 5 Jan 2024.