Esophageal Squamous Cell CarcinomaPhase 3NCT05495152
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 3 study testing Sintilimab in people with Esophageal Squamous Cell Carcinoma, run by Henan Cancer Hospital at 2 sites in China.
Trial summary
No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2022to 31 Aug 2028
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven squamous cell carcinoma.
- Tumours are located in the thoracic oesophagus.
- Age is between 18 years and 70 years.
- ECOG performance status of 0 or 1.
- Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologically proven T1-2N+M0 after upfront surgery.
- No metastatic cervical lymph nodes.
Show all 13Show fewer
- R0 resection is achieved by the minimally invasive esophagectomy (MIE) or open McKeown approach with total two-field lymph nodes dissection or three-field lymph nodes dissection.
- No prior therapy was administered against other cancers.
- Adequate bone marrow function: white blood cell count ≥ 4×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/l; platelets ≥ 100×109/L; haemoglobin ≥ 9 g/dl.
- Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 × ULN (ULN as per institutional standard).
- Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using the Cockcroft-Gault formula.
- Normal thyroid function.
- Written consent is obtained.
Who cannot join
- Patients receive neoadjuvant chemoradiation therapy.
- Patients with pathological complete response (pCR).
- No. of lymph node dissection < 15.
- Patients with clinical stages T1-2N+M0 and receive upfront surgery.
- Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy.
- Patients requiring systemic steroid medication.
Show all 15Show fewer
- Patients with severe postoperative complications and not suitable for adjuvant therapy.
- Synchronous or metachronous (within 5 years) double cancers.
- Patients ever received immunotherapy.
- Active infection requiring systemic therapy.
- Patients ever received organ transplant or allogenic haemopoietic stem cell transplantation.
- Patients with human immunodeficiency virus (HIV) infection.
- Psychiatric disease.
- Pregnant or lactating women or women of childbearing potential.
- Hypersensitivity for Sintilimab.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Haibo Sun, +8615188301091, sunny-haipo@hotmail.com
Haibo Sun
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Haibo Sun, MD, 15188301091, sunny-haipo@hotmail.com
About this study
Official title: Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma: a Multi-Centre, Open-Label, Randomized, Controlled, Clinical Trial (HCHTOG2203)
No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).
- 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
Patients in adjuvant arm receive 17 cycles of Sintilimab within 4 to 12 weeks after esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Arm | Experimental | Patients in arm A receive 17 cycles of Sintilimab within 4 to 12 weeks after esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks. Receives: Drug: Sintilimab |
| Observation Arm | No intervention | Patients in observation arm receive routine follow-up after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS)
DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death.
Measured: DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death , assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Henan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Haibo Sun, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495152
- Sponsor's protocol ID
- HCHTOG2203
- Status last verified
- Oct 2024
- First submitted
- 8 Aug 2022
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun HB, Xing WQ, Liu XB, Yang SJ, Chen PN, Liu SL, Li P, Ma YX, Jiang D, Yan S. A multicenter randomized, controlled clinical trial of adjuvant sintilimab for esophageal squamous cell carcinoma. Future Oncol. 2023 Aug;19(26):1777-1784. doi: 10.2217/fon-2022-1255. Epub 2023 Sep 22.
PubMed 37737025
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma: a Multi-Centre, Open-Label, Randomized, Controlled, Clinical Trial (HCHTOG2203)
- ClinicalTrials.gov ID
- NCT05495152
- Acronym / sponsor ID
- HCHTOG2203
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 10 Aug 2022 (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.
No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Arm | Experimental | Drug: SintilimabPatients in arm A receive 17 cycles of Sintilimab within 4 to 12 weeks after esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks. |
| Observation Arm | No intervention | –Patients in observation arm receive routine follow-up after surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically proven squamous cell carcinoma.
- Tumours are located in the thoracic oesophagus.
- Age is between 18 years and 70 years.
- ECOG performance status of 0 or 1.
- Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologically proven T1-2N+M0 after upfront surgery.
Key exclusion criteria (15 listed)
- Patients receive neoadjuvant chemoradiation therapy.
- Patients with pathological complete response (pCR).
- No. of lymph node dissection < 15.
- Patients with clinical stages T1-2N+M0 and receive upfront surgery.
- Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy.
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 |
|---|---|---|
| SintilimabPatients in adjuvant arm receive 17 cycles of Sintilimab within 4 to 12 weeks after esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks. | Drug | Adjuvant Arm |
Primary outcome
Disease-free Survival (DFS)
Time frame: DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death , assessed up to 36 months
DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death.
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 2 Oct 2024.
- Derived from this study: PubMed 37737025Sun HB, Xing WQ, Liu XB, Yang SJ, Chen PN, Liu SL, Li P, Ma YX, Jiang D, Yan S. A multicenter randomized, controlled clinical trial of adjuvant sintilimab for esophageal squamous cell carcinoma. Future Oncol. 2023 Aug;19(26):1777-1784. doi: 10.2217/fon-2022-1255. Epub 2023 Sep 22.
- Individual participant dataSharing planned: No
Related trials for Esophageal Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sintilimab in people with Esophageal Squamous Cell Carcinoma, run by Henan Cancer 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 13 inclusion and 15 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 2 Oct 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 phase mean?
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?
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 Haibo Sun (15188301091, sunny-haipo@hotmail.com), 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: DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death , assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495152, which also lists 1 linked publication.
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 Oct 2024.