ESCCPhase 2NCT05547828
Efficacy and Safety of Tislelizumab and Nab-paclitaxel Combined With Low-dose Radiotherapy in Patients With Stage IVb Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Tislelizumab combined with chemoradiotherapy in people with ESCC, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial summary
This study is a single-arm, prospective, open-label clinical study to evaluate the safety and efficacy of tislelizumab combined with chemoradiotherapy in first-line treatment of patients with stage IVb esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESCC
- What is being tested?
- Tislelizumab combined with chemoradiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 20 Dec 2024
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of Esophageal squamous cell carcinoma
- -diagnosed with stage IVb Esophageal squamous cell carcinoma (UICC/AJCC 8th edition TNM staging system) by CT/MRI/PET-CT/ECT, laboratory examination and pathological examination results; specific: any T, any N, M1;
- No previous anti-tumor treatment; expected survival period of more than half a year; 3.18-75 years old, PS score 0-1;
- 4. According to RECIST1.1 criteria, there is at least one measurable target lesion, and tumor imaging evaluation is performed within 28 days before the first dose; 5. Major organ function is normal, that is, the following criteria are met: 6. No active autoimmune disease; 7. No active hepatitis; 8. General conditions or medical complications can tolerate radiotherapy, chemotherapy and immunotherapy; 9. No history of malignant tumor, no previous anti-tumor therapy; 10. For premenopausal or surgically sterilized female patients: Consent to abstinence or use of effective contraception during treatment and for at least 7 months after the last dose of study treatment; 11. Understand and sign the informed consent form for this study.
Who cannot join
- Previous antitumor therapy or radiation therapy for any malignant tumor;
- patients receiving standard treatment;
- concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
- Has undergone major surgical procedures unrelated to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
- Serious heart disease or discomfort, including but not limited to the following:
- Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption;
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- Known history of allergy to the drug components of this regimen; history of immunodeficiency, including positive HIV test, positive HBV/HCV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period and within 7 months after the last study drug;
- Have serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition that the investigator considers the patient unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Tislelizumab Combined With Chemoradiotherapy in First-line Treatment of Stage IVb Esophageal Squamous Cell Carcinoma
This study is a single-arm, prospective, open-label clinical study to evaluate the safety and efficacy of tislelizumab combined with chemoradiotherapy in first-line treatment of patients with stage IVb esophageal squamous cell carcinoma.
Read the detailed description
This study is a single-center, prospective, single-arm, open-label study. It will explore the efficacy and safety of tislelizumab combined with nab-paclitaxel in the first-line treatment of stage IVb esophageal squamous cell carcinoma on the basis of low-dose radiotherapy（40Gy/20f，5次/w）. To explore new treatment modalities and prolong patient survival.
- Conditions
- ESCC
- Being tested
- Tislelizumab combined with chemoradiotherapy
- Keywords
- PD-1, RCT, Ⅳb ESCC, 1 line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab combined with chemoradiotherapyDrug
Tislelizumab: According to the instructions of tislelizumab, 200 mg intravenously on the first day of each cycle, 21 days as a cycle.
Nab-paclitaxel: white purple: 100mg/m2 intravenous infusion on d1.8.15 (during chemotherapy) 100mg/m2 intravenous infusion q3w ╳ 3 cycles (during consolidation therapy) Radiotherapy: 40Gy/20f, 5 times/w, (esophageal primary tumor and metastatic lymph nodes)
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with chemoradiotherapy | Other | Tislelizumab: According to the instructions of tislelizumab, 200 mg intravenously on the first day of each cycle, 21 days as a cycle.
Nab-paclitaxel: white purple: 100mg/m2 intravenous infusion on d1.8.15 (during chemotherapy) 100mg/m2 intravenous infusion q3w ╳ 3 cycles (during consolidation therapy) Radiotherapy: 40Gy/20f, 5 times/w, (esophageal primary tumor and metastatic lymph nodes) Receives: Drug: Tislelizumab combined with chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
It is defined as the number of subjects with the best response effect as complete remission (CR) or partial remission (PR) during the period from the start of the subjects receiving the treatment regimen of this study to the progression of the subjects' disease in the total number of subjects in the analysis data set. percentage of the population（%）.
Measured: Up to 24 months
Secondary outcomes (4)
Disease Control Rate (DCR)
Defined as the number of subjects whose tumors shrank or remained stable for a certain period of time from receiving the treatment regimen of this study to the progression of the subject's disease, including complete remission (CR) and partial remission (PR) in the analysis data set percentage of the total population（%）.
Measured: Up to 24 months
Progression Free Survival (PFS)
Defined as the time from randomization to tumor progression in any aspect or death from any cause（Unit: month）.
Assessed according to RECIST 1.1 criteria, analysis of this indicator included tumor evaluation results during study treatment and follow-up. If the patient has several indicators that can be judged as PD, the first indicator will be used for PFS analysis; recurrence, new lesions or death are considered to have reached the end of the study, and the patient is treated with other systemic or target-targeted anti-PD. Tumor treatment is also considered tumor progression.
Measured: Up to 24 months
Overall survival (OS)
Defined as the time from randomization to death from any cause（Unit: month）.
Measured: Up to 24 months
Drug-Related Safety Indicators
Exposure to the investigational drug and incidence, nature, and severity of adverse events, including serious adverse events（n，%）。
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start20 Dec 2022 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547828
- Sponsor's protocol ID
- TD-CR-ESCC
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 21 Sep 2022
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tislelizumab Combined With Chemoradiotherapy in First-line Treatment of Stage IVb Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05547828
- Acronym / sponsor ID
- TD-CR-ESCC
- Conditions
- ESCC
- Keywords
- PD-1, RCT, Ⅳb ESCC, 1 line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 21 Sep 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.
This study is a single-arm, prospective, open-label clinical study to evaluate the safety and efficacy of tislelizumab combined with chemoradiotherapy in first-line treatment of patients with stage IVb esophageal squamous cell carcinoma.
Detailed description
This study is a single-center, prospective, single-arm, open-label study. It will explore the efficacy and safety of tislelizumab combined with nab-paclitaxel in the first-line treatment of stage IVb esophageal squamous cell carcinoma on the basis of low-dose radiotherapy（40Gy/20f，5次/w）. To explore new treatment modalities and prolong patient survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with chemoradiotherapy | Other | Drug: Tislelizumab combined with chemoradiotherapyTislelizumab: According to the instructions of tislelizumab, 200 mg intravenously on the first day of each cycle, 21 days as a cycle. Nab-paclitaxel: white purple: 100mg/m2 intravenous infusion on d1.8.15 (during chemotherapy) 100mg/m2 intravenous infusion q3w ╳ 3 cycles (during consolidation therapy) Radiotherapy: 40Gy/20f, 5 times/w, (esophageal primary tumor and metastatic lymph nodes) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria of Esophageal squamous cell carcinoma
- -diagnosed with stage IVb Esophageal squamous cell carcinoma (UICC/AJCC 8th edition TNM staging system) by CT/MRI/PET-CT/ECT, laboratory examination and pathological examination results; specific: any T, any N, M1;
- No previous anti-tumor treatment; expected survival period of more than half a year; 3.18-75 years old, PS score 0-1;
- 4. According to RECIST1.1 criteria, there is at least one measurable target lesion, and tumor imaging evaluation is performed within 28 days before the first dose; 5. Major organ function is normal, that is, the following criteria are met: 6. No active autoimmune disease; 7. No active hepatitis; 8. General conditions or medical complications can tolerate radiotherapy, chemotherapy and immunotherapy; 9. No history of malignant tumor, no previous anti-tumor therapy; 10. For premenopausal or surgically sterilized female patients: Consent to abstinence or use of effective contraception during treatment and for at least 7 months after the last dose of study treatment; 11. Understand and sign the informed consent form for this study.
Key exclusion criteria (9 listed)
- Previous antitumor therapy or radiation therapy for any malignant tumor;
- patients receiving standard treatment;
- concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
- Has undergone major surgical procedures unrelated to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
- Serious heart disease or discomfort, including but not limited to the following:
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 |
|---|---|---|
| Tislelizumab combined with chemoradiotherapyTislelizumab: According to the instructions of tislelizumab, 200 mg intravenously on the first day of each cycle, 21 days as a cycle. Nab-paclitaxel: white purple: 100mg/m2 intravenous infusion on d1.8.15 (during chemotherapy) 100mg/m2 intravenous infusion q3w ╳ 3 cycles (during consolidation therapy) Radiotherapy: 40Gy/20f, 5 times/w, (esophageal primary tumor and metastatic lymph nodes) | Drug | Tislelizumab combined with chemoradiotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 24 months
It is defined as the number of subjects with the best response effect as complete remission (CR) or partial remission (PR) during the period from the start of the subjects receiving the treatment regimen of this study to the progression of the subjects' disease in the total number of subjects in the analysis data set. percentage of the population（%）.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 24 months
Progression Free Survival (PFS)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Drug-Related Safety Indicators
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab combined with chemoradiotherapy in people with ESCC, run by The First Affiliated Hospital of Xinxiang Medical College.
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 4 inclusion and 9 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 21 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingqin Zhang (+8615936504409, zhangqingqin814@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 24 months). 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 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.