Esophageal CarcinomaBest-EECNCT06009705
Toripalimab Combined With Radiotherapy and S-1 for Older Patients With Esophageal Cancer
An observational study of Esophageal Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This trial aims to assess efficacy and safety of toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy for older patients with stage II-III esophageal cancer. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Esophageal Carcinoma
- What is being tested?
- toripalimab
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Apr 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older esophageal cancer patients who receive toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy.
Who may be able to join
- Voluntary participation and written signed informed consent;
- Age ≥65 years old, gender is not limited;
- Histologically or cytologically confirmed esophageal cancer;
- Elderly patients with stage I-III esophageal cancer who are inoperable or refuse to undergo surgery and can tolerate immunotherapy combined with S-1 and radiotherapy;
- Physical status score ECOG 0-2;
- Expected survival ≥ 6 months;
- no serious abnormalities of haematopoietic, cardiac, pulmonary, hepatic and renal functions and immunodeficiency (Haematology: white blood cells ≥3.5×109/L; neutrophils ≥1.5×109/L; haemoglobin ≥90g/L; platelets ≥100×109/L. Liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) ≤2.5 times the upper limit of normal; creatinine ≤1.5 times the upper limit of normal; albumin ≥30 g/L. Coagulation: International Normalised Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, PT or INR is acceptable as long as the PT or INR is within the range of the anticoagulant drug formulation. Echocardiographic assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%). Pulmonary function FEV1 ≥70% of % of predicted value and DLCO ≥60% of % of predicted value).
- Have at least one measurable lesion as judged by RECIST 1.1 criteria.
Who cannot join
- Distant organ metastases (excluding supraclavicular lymph nodes) as determined by CT evaluation during screening and prior imaging;
- Pre-treatment with oesophageal fistula, perforation, or malignant disease;
- have received prior radiotherapy to the chest;
- having any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included if hormone replacement therapy is effective), etc.), and a history of immunosuppressive drug use within 28 days, with the exception of the use of hormones for the purpose of dealing with toxicity from radiotherapy;
- Previously received or are receiving other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1, or are currently participating in other interventional clinical studies for treatment;
- Have received other anti-tumour therapy (including herbal therapy with anti-tumour effect) within 4 weeks prior to the first dose of the study; have received long-term systemic immunotherapy or hormone therapy (except physiological replacement therapy, e.g., oral thyroxine for hypothyroidism) within 4 weeks prior to the first dose of the study; and have been treated with other experimental drugs or interventional clinical studies within 4 weeks prior to the first dose of the study;
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- Known hypersensitivity to large protein preparations, or to any of the components within toripalimab, S-1 capsules and their preparations;
- Patients with uncontrolled clinical cardiac symptoms or disease such as (1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- with congenital or acquired immune function defects (e.g., HIV-infected patients), active hepatitis B (HBV-DNA ≥104 copies/ml) or hepatitis C (hepatitis C antibody-positive with HCV-RNA above the lower limit of detection of the analytical method), or active tuberculosis;
- Have an active infection or unexplained fever >38.5°C within 2 weeks prior to screening (at the investigator's discretion, subjects may be enrolled for fever arising from tumours);
- History of malignancy other than oesophageal cancer within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix;
- In the judgement of the investigator, the subject has other factors that may cause him/her to be forced to terminate the study in the middle of the study, e.g., suffering from other serious illnesses (including psychiatric illnesses) that require comorbid treatment, family or social factors that may affect the safety of the subject or the collection of trial data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Wenbin Shen, PhD, +86 15831183879, wbshen1979@sina.com
Hesong Wang, PhD, +86 18810775196, wanghesongmz@163.com
About this study
Official title: Efficacy and Safety of Toripalimab Combined With Radiotherapy and S-1 Followed by Adjuvant Toripalimab Maintenance Therapy for Older Patients With Esophageal Cancer
This trial aims to assess efficacy and safety of toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy for older patients with stage II-III esophageal cancer.
Read the detailed description
With the aging of the population, the number of elderly esophageal cancer patients is gradually increasing. For non-metastatic esophageal cancer patients, surgery is the first choice of treatment, but elderly esophageal cancer patients are often unable to tolerate surgical treatment due to more comorbidities and poor physical condition, etc. The results of previous studies have shown that the effect of radiotherapy treatment is also unsatisfactory, and the 5-year survival rate of esophageal cancer patients treated with radiotherapy is only 15-25%, which makes the clinical treatment of elderly patients even more difficult due to their poor physical tolerance. A multicentre randomised phase III clinical trial (NCT02813967) demonstrated that concurrent radiotherapy and S-1 treatment in elderly patients with esophageal cancer was tolerable and provided significant benefit compared with radiotherapy alone. In recent years, tumor immunotherapy has shown some efficacy in the field of cancer treatment by activating the body's own immune system to fight tumors. Therefore, this trial aims to assess efficacy and safety of toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy for older patients with stage II-III esophageal cancer. The primary study endpoints are objective remission rate (ORR), disease control rate (DCR), duration of remission (DOR) and safety. Secondary study endpoints are overall survival (OS) and progression-free survival (PFS).
- Conditions
- Esophageal Carcinoma
- Being tested
- toripalimab
- Keywords
- esophageal carcinoma, esophageal cancer, immunotherapy, chemoradiotherapy, toripalimab
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toripalimabDrug
JS001, the active ingredient of toripalimab injection, independently developed by Shanghai Junshi Biomedical Technology Co., Ltd, is an independently developed novel recombinant humanised (degree of 97%) anti-PD-1 monoclonal antibody (Chinese Patent License No. CN104250302B, PCT Patent Publication No. WO2014/206107A1), belonging to the human IgG4/Kappa subtype, and introducing a point mutation at the Serine to Proline (S228P) protein site 228 in the hinge region of the IgG4 heavy chain.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of objective remission rate (ORR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Objective remission rate (ORR): defined as the proportion of subjects whose tumor volume shrinks to a pre-specified value and can be maintained for the minimum time frame required, incorporating cases in complete remission (CR) and partial remission (PR).
Measured: 2022/10/1-2026/4/30
Assessment of disease control rate (DCR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Disease control rate (DCR): the proportion of patients whose tumors shrank or were stable and remained so for a certain period of time, including complete remission (CR), partial remission (PR) and stable disease (SD).
Measured: 2022/10/1-2026/4/30
Assessment of duration of remission (DOR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Duration of remission (DOR): refers to the time between the start of the first assessment of the tumor as complete remission (CR) or partial remission (PR) and the first assessment of PD or death from any cause.
Measured: 2022/10/1-2026/4/30
Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events.
Adverse events are observed during the course of the study and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).
Measured: 2022/10/1-2026/4/30
Secondary outcomes (2)
Assessment of overall survival (OS) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). OS is defined as the time from the start of enrollment to death from any cause.
Measured: 2022/10/1-2026/4/30
Assessment of progression-free survival (PFS) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). PFS is defined as the time from the start of enrollment until tumor progression or death from any cause.
Measured: 2022/10/1-2026/4/30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Oct 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenbin Shen, PhD, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009705
- Sponsor's protocol ID
- Best-EEC
- Acronym
- Best-EEC
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Toripalimab Combined With Radiotherapy and S-1 Followed by Adjuvant Toripalimab Maintenance Therapy for Older Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06009705
- Acronym / sponsor ID
- Best-EEC / Best-EEC
- Conditions
- Esophageal Carcinoma
- Keywords
- esophageal carcinoma, esophageal cancer, immunotherapy, chemoradiotherapy, toripalimab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 24 Aug 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 trial aims to assess efficacy and safety of toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy for older patients with stage II-III esophageal cancer.
Detailed description
With the aging of the population, the number of elderly esophageal cancer patients is gradually increasing. For non-metastatic esophageal cancer patients, surgery is the first choice of treatment, but elderly esophageal cancer patients are often unable to tolerate surgical treatment due to more comorbidities and poor physical condition, etc. The results of previous studies have shown that the effect of radiotherapy treatment is also unsatisfactory, and the 5-year survival rate of esophageal cancer patients treated with radiotherapy is only 15-25%, which makes the clinical treatment of elderly patients even more difficult due to their poor physical tolerance. A multicentre randomised phase III clinical trial (NCT02813967) demonstrated that concurrent radiotherapy and S-1 treatment in elderly patients with esophageal cancer was tolerable and provided significant benefit compared with radiotherapy alone. In recent years, tumor immunotherapy has shown some efficacy in the field of cancer treatment by activating the body's own immune system to fight tumors. Therefore, this trial aims to assess efficacy and safety of toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy for older patients with stage II-III esophageal cancer. The primary study endpoints are objective remission rate (ORR), disease control rate (DCR), duration of remission (DOR) and safety. Secondary study endpoints are overall survival (OS) and progression-free survival (PFS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older esophageal cancer patients who receive toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy.
Key inclusion criteria (8 listed)
- Voluntary participation and written signed informed consent;
- Age ≥65 years old, gender is not limited;
- Histologically or cytologically confirmed esophageal cancer;
- Elderly patients with stage I-III esophageal cancer who are inoperable or refuse to undergo surgery and can tolerate immunotherapy combined with S-1 and radiotherapy;
- Physical status score ECOG 0-2;
Key exclusion criteria (12 listed)
- Distant organ metastases (excluding supraclavicular lymph nodes) as determined by CT evaluation during screening and prior imaging;
- Pre-treatment with oesophageal fistula, perforation, or malignant disease;
- have received prior radiotherapy to the chest;
- having any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included if hormone replacement therapy is effective), etc.), and a history of immunosuppressive drug use within 28 days, with the exception of the use of hormones for the purpose of dealing with toxicity from radiotherapy;
- Previously received or are receiving other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1, or are currently participating in other interventional clinical studies for treatment;
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 |
|---|---|---|
| toripalimabJS001, the active ingredient of toripalimab injection, independently developed by Shanghai Junshi Biomedical Technology Co., Ltd, is an independently developed novel recombinant humanised (degree of 97%) anti-PD-1 monoclonal antibody (Chinese Patent License No. CN104250302B, PCT Patent Publication No. WO2014/206107A1), belonging to the human IgG4/Kappa subtype, and introducing a point mutation at the Serine to Proline (S228P) protein site 228 in the hinge region of the IgG4 heavy chain. | Drug | – |
Primary outcome
Assessment of objective remission rate (ORR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Time frame: 2022/10/1-2026/4/30
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Objective remission rate (ORR): defined as the proportion of subjects whose tumor volume shrinks to a pre-specified value and can be maintained for the minimum time frame required, incorporating cases in complete remission (CR) and partial remission (PR).
Assessment of disease control rate (DCR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Time frame: 2022/10/1-2026/4/30
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Disease control rate (DCR): the proportion of patients whose tumors shrank or were stable and remained so for a certain period of time, including complete remission (CR), partial remission (PR) and stable disease (SD).
Assessment of duration of remission (DOR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Time frame: 2022/10/1-2026/4/30
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Duration of remission (DOR): refers to the time between the start of the first assessment of the tumor as complete remission (CR) or partial remission (PR) and the first assessment of PD or death from any cause.
Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events.
Time frame: 2022/10/1-2026/4/30
Adverse events are observed during the course of the study and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).
2 secondary outcomes
Assessment of overall survival (OS) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Time frame: 2022/10/1-2026/4/30
Assessment of progression-free survival (PFS) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.
Time frame: 2022/10/1-2026/4/30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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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.
Wenbin Shen, PhD principal investigator
Hebei Medical University Fourth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Carcinoma, run by Hebei Medical University Fourth 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 8 inclusion and 12 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 Aug 2023. 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.
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?
Contact Wenbin Shen, PhD (+86 15831183879, wbshen1979@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of objective remission rate (ORR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy. (time frame: 2022/10/1-2026/4/30). The study lists 4 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 Aug 2023.