Esophageal Squamous Cell CarcinomaPhase 2NCT06468644
Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing chemoradiotherapy （CRT）+sintilimab 1 and CRT+sintilimab 2 in people with Esophageal Squamous Cell Carcinoma, run by Fujian Cancer Hospital.
Trial summary
This study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma. 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?
- chemoradiotherapy （CRT）+sintilimab 1 and CRT+sintilimab 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 17 Jun 2024to Jun 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
- ≥18 years old
- Histopathological examination of the primary biopsy confirmed the diagnosis of locally advanced esophageal squamous cell carcinoma
- At least one measurable lesion
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- With adequate organs function
Who cannot join
- Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
- Patients who have a higher risk of bleeding or perforation due to the tumor\'s obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
- Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma.
Read the detailed description
This study was designed as a two cohorts, phase II trial. Subjects will receive different doses of radiotherapy combined with sintilimab. The primary endpoint is progression-free survival.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- chemoradiotherapy （CRT）+sintilimab 1, CRT+sintilimab 2
- 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.
chemoradiotherapy （CRT）+sintilimab 1Drug
radiotherapy (50.4Gy/1.8Gy/28f)+chemotherapy (paclitaxel 150mg/m2 D1+cisplatin 25mg/m2 D1-3，Q3W)+Sintilimab (200mg, iv, D1, Q3W) Consolidation therapy: Sintilimab: 200mg, iv, D1, Q3W
CRT+sintilimab 2Drug
radiotherapy (60Gy/2Gy/30f)+chemotherapy (paclitaxel 150mg/m2 D1+cisplatin 25mg/m2 D1-3，Q3W)+Sintilimab (200mg, iv, D1, Q3W) Consolidation therapy: Sintilimab: 200mg, iv, D1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | dose 1 of radiotherapy+sintilimab Receives: Drug: chemoradiotherapy （CRT）+sintilimab 1 |
| Group B | Experimental | dose 2 of radiotherapy+sintilimab Receives: Drug: CRT+sintilimab 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
the time from random assignment in a clinical trial to disease progression or death from any cause
Measured: 1 years
Incidence rate of adverse events
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
Measured: 3 years
Secondary outcomes (2)
overall survival
the time from randomization to death
Measured: 3 years
Objective Response Rate
the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors 1.1
Measured: 3 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start17 Jun 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 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 Fujian 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468644
- Sponsor's protocol ID
- ConES-ljc
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06468644
- Acronym / sponsor ID
- ConES-ljc
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 17 Jun 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Jun 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.
This study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma.
Detailed description
This study was designed as a two cohorts, phase II trial. Subjects will receive different doses of radiotherapy combined with sintilimab. The primary endpoint is progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: chemoradiotherapy （CRT）+sintilimab 1dose 1 of radiotherapy+sintilimab |
| Group B | Experimental | Drug: CRT+sintilimab 2dose 2 of radiotherapy+sintilimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Histopathological examination of the primary biopsy confirmed the diagnosis of locally advanced esophageal squamous cell carcinoma
- At least one measurable lesion
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- With adequate organs function
Key exclusion criteria (3 listed)
- Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
- Patients who have a higher risk of bleeding or perforation due to the tumor\'s obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
- Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
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 |
|---|---|---|
| chemoradiotherapy （CRT）+sintilimab 1radiotherapy (50.4Gy/1.8Gy/28f)+chemotherapy (paclitaxel 150mg/m2 D1+cisplatin 25mg/m2 D1-3，Q3W)+Sintilimab (200mg, iv, D1, Q3W) Consolidation therapy: Sintilimab: 200mg, iv, D1, Q3W | Drug | Group A |
| CRT+sintilimab 2radiotherapy (60Gy/2Gy/30f)+chemotherapy (paclitaxel 150mg/m2 D1+cisplatin 25mg/m2 D1-3，Q3W)+Sintilimab (200mg, iv, D1, Q3W) Consolidation therapy: Sintilimab: 200mg, iv, D1, Q3W | Drug | Group B |
Primary outcome
progression free survival
Time frame: 1 years
the time from random assignment in a clinical trial to disease progression or death from any cause
Incidence rate of adverse events
Time frame: 3 years
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
2 secondary outcomes
overall survival
Time frame: 3 years
Objective Response Rate
Time frame: 3 months after therapy
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 21 Jun 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemoradiotherapy （CRT）+sintilimab 1 and CRT+sintilimab 2 in people with Esophageal Squamous Cell Carcinoma, run by Fujian Cancer 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 3 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: opening soon, as of the sponsor's last update on 21 Jun 2024. 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?
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 Jiancheng Li (86-13906900190, jianchengli6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 1 years). The study lists 2 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 21 Jun 2024.