Esophageal CancerPhase 2/3NCT05817201
Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy
A Phase 2/3 study testing Toripalimab, Tegafur and IMRT in people with Esophageal Cancer and Radiation Therapy, run by Taizhou Hospital at 2 sites in China.
Trial summary
The goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer. Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Esophageal Cancer, Radiation Therapy, Immunotherapy
- What is being tested?
- Toripalimab, Tegafur and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2022to 31 Dec 2024
- 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 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Carcinoma of the esophagus confirmed histologically or cytologically. Lesions that can be measured according to the RECIST standard. AJCC/UICC Staging of Esophageal Carcinoma (Sixth Edition) Clinical Staging Ⅱa to Ⅲ.
- Age ≥ 70 years ≤ 85 years old. The ECOG physical state score is 0 to 1. No esophageal perforation, active esophageal bleeding, or significant invasion of trachea or thoracic aorta.
- Patients with not previously received chest radiation and speech therapy, immunotherapy, or biological therapy.
- Hemoglobin ≥ 100g/L, platelets ≥ 100 10^9/L, absolute neutrophil count ≥ 1.5 10^9/L。 Serum creatinine ≤ 1.25 times UNL or creatinine clearance ≥ 60 mL/min. Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, and alkaline phosphatase ≤ 5 times UNL.
- No history of interstitial pneumonia or previous interstitial pneumonia. FEV1>0.8L。
- The patient signs a formal informed consent form.
Who cannot join
- Patients with chest radiation, chemotherapy, or surgical resection of esophageal cancer before the start of this trial Patients with multifocal esophageal cancer, and the lower boundary of the primary lesion of the esophagus is less than 3cm from the esophageal gastric junction.
- Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a previous history of interstitial pneumonia.
- Patients with obvious esophageal ulcer, moderate or above pain in chest and back, and symptoms of esophageal perforation.
- Patients who cannot understand or may not comply with the test requirements. Patients with other malignant lesions, except for curable skin cancer (non melanoma), cervical carcinoma in situ or malignant disease that has been cured for ≥ 5 years.
- Researchers believe that some obvious diseases should be excluded from this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Haihua Yang
Taizhou, Zhejiang, 317000
Haihua Yang, 13819639006, yhh93181@hotmail.com
Haihua Yang, MD
- Recruiting
Taizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, 318025
Haihua Yang, 13819639006, yhh93181@hotmail.com
Haihua Yang, MD
About this study
Official title: A Phase II and III, Randomized, Multicenter Clinical Study: Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy
The goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer.
Read the detailed description
Older patients with esophageal cancer are universally intolerant to chemotherapy.
This study is performed to explore a non-chemotherapy strategy for elderly esophageal cancer patients.
Participants will be treated with Toripalimab monoclonal antibody maintenance versus S-1 combined with radiotherapy, intended to explore the efficacy and safety of non-chemotherapy strategy for elderly esophageal cancer patients.
- Conditions
- Esophageal Cancer, Radiation Therapy, Immunotherapy, Chemotherapy
- Being tested
- Toripalimab, Tegafur, IMRT
- 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
Also called JS001, TAB001
Toripalimab 240mg day7 and day 28，every 3 weeks 1month after radiotherapy，until progression or 1 years or intolerant.
TegafurDrug
Also called S-1
Tegafur 70mg/m2/day day 1 to day 14，and day 29 to day42.
IMRTRadiation
Also called Irradiation, intensity modulation radiation therapy
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab & Radiotherapy | Experimental | Toripalimab, 240mg/d, radiotherapy D7, D28; Thoracic radiotherapy, 54Gy/25F, IMRT; Maintenance Toripalimab therapy after completed radiotherapy, 240mg/Q3W, until progression or 1 years or intolerant Receives: Drug: Toripalimab; Radiation: IMRT |
| Chemotherapy & Radiotherapy | Active comparator | Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT. Receives: Drug: Tegafur; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The OS was defined as the duration from the date of of initiation of treatment to the date of death from any cause or censored at the date of the last follow-up.
Measured: Time Frame: 2 years
Secondary outcomes (1)
Progression-Free survival
Progression-free survival (PFS) will be calculated from the date of initiation of treatment until the day of documented failure (local recurrence or metastasis occurrence) or until the date of the last follow-up visit.
Measured: Time Frame: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihua Yang, Taizhou Hospital
- Investigators
- Taizhou Enze Medical Center(Group) Enze Hospital Yang, MD, Principal investigator, Taizhou Enze Medical Center Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817201
- Sponsor's protocol ID
- TREEN Trial
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II and III, Randomized, Multicenter Clinical Study: Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy
- ClinicalTrials.gov ID
- NCT05817201
- Acronym / sponsor ID
- TREEN Trial
- Conditions
- Esophageal Cancer, Radiation Therapy, Immunotherapy, Chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 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.
The goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer.
Detailed description
Older patients with esophageal cancer are universally intolerant to chemotherapy.
This study is performed to explore a non-chemotherapy strategy for elderly esophageal cancer patients.
Participants will be treated with Toripalimab monoclonal antibody maintenance versus S-1 combined with radiotherapy, intended to explore the efficacy and safety of non-chemotherapy strategy for elderly esophageal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toripalimab & Radiotherapy | Experimental | Drug: Toripalimab, Radiation: IMRTToripalimab, 240mg/d, radiotherapy D7, D28; Thoracic radiotherapy, 54Gy/25F, IMRT; Maintenance Toripalimab therapy after completed radiotherapy, 240mg/Q3W, until progression or 1 years or intolerant |
| Chemotherapy & Radiotherapy | Active comparator | Drug: Tegafur, Radiation: IMRTTegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT. |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Carcinoma of the esophagus confirmed histologically or cytologically. Lesions that can be measured according to the RECIST standard. AJCC/UICC Staging of Esophageal Carcinoma (Sixth Edition) Clinical Staging Ⅱa to Ⅲ.
- Age ≥ 70 years ≤ 85 years old. The ECOG physical state score is 0 to 1. No esophageal perforation, active esophageal bleeding, or significant invasion of trachea or thoracic aorta.
- Patients with not previously received chest radiation and speech therapy, immunotherapy, or biological therapy.
- Hemoglobin ≥ 100g/L, platelets ≥ 100 10^9/L, absolute neutrophil count ≥ 1.5 10^9/L。 Serum creatinine ≤ 1.25 times UNL or creatinine clearance ≥ 60 mL/min. Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, and alkaline phosphatase ≤ 5 times UNL.
- No history of interstitial pneumonia or previous interstitial pneumonia. FEV1>0.8L。
Key exclusion criteria (5 listed)
- Patients with chest radiation, chemotherapy, or surgical resection of esophageal cancer before the start of this trial Patients with multifocal esophageal cancer, and the lower boundary of the primary lesion of the esophagus is less than 3cm from the esophageal gastric junction.
- Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a previous history of interstitial pneumonia.
- Patients with obvious esophageal ulcer, moderate or above pain in chest and back, and symptoms of esophageal perforation.
- Patients who cannot understand or may not comply with the test requirements. Patients with other malignant lesions, except for curable skin cancer (non melanoma), cervical carcinoma in situ or malignant disease that has been cured for ≥ 5 years.
- Researchers believe that some obvious diseases should be excluded from this study.
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 |
|---|---|---|
| ToripalimabAlso: JS001, TAB001Toripalimab 240mg day7 and day 28，every 3 weeks 1month after radiotherapy，until progression or 1 years or intolerant. | Drug | Toripalimab & Radiotherapy |
| TegafurAlso: S-1Tegafur 70mg/m2/day day 1 to day 14，and day 29 to day42. | Drug | Chemotherapy & Radiotherapy |
| IMRTAlso: Irradiation, intensity modulation radiation therapyPGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W | Radiation | Chemotherapy & Radiotherapy, Toripalimab & Radiotherapy |
Primary outcome
Overall survival
Time frame: Time Frame: 2 years
The OS was defined as the duration from the date of of initiation of treatment to the date of death from any cause or censored at the date of the last follow-up.
1 secondary outcome
Progression-Free survival
Time frame: Time Frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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.
Taizhou Enze Medical Center(Group) Enze Hospital Yang, MD principal investigator
Taizhou Enze Medical Center Group
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 Toripalimab, Tegafur and IMRT in people with Esophageal Cancer and Radiation Therapy, run by Taizhou 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 5 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 18 Apr 2023. 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?
Contact Haihua Yang, MD (13819639006, yhh93181@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Time Frame: 2 years). 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 18 Apr 2023.