Immunotherapy Esophagus CancerPhase 2NCT05515315
Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Tislelizumab, Albumin paclitaxel and Nedaplatin in people with Immunotherapy Esophagus Cancer, run by Fuzhou General Hospital at 1 site in China.
Trial summary
To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Immunotherapy Esophagus Cancer
- What is being tested?
- Tislelizumab, Albumin paclitaxel and Nedaplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2022to 31 May 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);;
- Aged 18-70, both sexes;
- ECOG score 0-1
- The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1;
- Adequate organ and bone marrow function, meeting the following definitions:
- Blood routine (no blood transfusion, no granulocyte colony-stimulating factor [G-CSF], and no other drugs were used within 14 days before treatment);Absolute neutrophil count (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥100×109/L;
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- Blood biochemistry Creatinine clearance rate ≥60 mL/min;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
- Expected survival time > 6 months;
- Fertile female subjects and male subjects with partners of reproductive age are required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last treatment;
- Patients who volunteered to participate in this study and signed the informed consent form.
Who cannot join
- A history of fistula caused by primary tumor invasion;
- Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization);
- Known intolerance or resistance to chemotherapy specified in the trial protocol;
- have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy);
- Patients with active autoimmune disease or a history of autoimmune disease that may relapse, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis and acute lung disease;
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- Severe chronic or active infection (including tuberculosis infection) requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment;
- Known history of HIV infection;
- Other malignancies (except cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix) in the past 5 years;
- Received live vaccine within 28 days before enrollment;
- while participating in another therapeutic clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ye zai sheng
Fuzhou, Fujian, 350500
Fu zhi chao, doctor, 13774562945 ext. 86, fauster1112@126.com
About this study
To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)
- Conditions
- Immunotherapy Esophagus Cancer
- Being tested
- Tislelizumab, Albumin paclitaxel, Nedaplatin, radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
Albumin paclitaxelDrug
Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks
NedaplatinDrug
Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks
radiotherapyRadiation
50-60Gy/25-30f
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with chemothapy | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Albumin paclitaxel; Drug: Nedaplatin; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Time from enrollment to the onset of disease progression or death
Measured: up to 24 months
Secondary outcomes (2)
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Measured: every 6 weeks （up to 24 months）
Overall survival (OS)
Defined from date of Signing ICF to date of first documentation of death from any cause or censored at the date of the last follow-up.
Measured: every 3 months (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 posted25 Aug 2022
- Study start31 May 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunotherapy Esophagus 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515315
- Sponsor's protocol ID
- TPT-ESCC
- Status last verified
- Feb 2024
- First submitted
- 19 Aug 2022
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05515315
- Acronym / sponsor ID
- TPT-ESCC
- Conditions
- Immunotherapy Esophagus Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 25 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.
To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)
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 chemothapy | Experimental | Drug: Tislelizumab, Drug: Albumin paclitaxel, Drug: Nedaplatin, Radiation: radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);;
- Aged 18-70, both sexes;
- ECOG score 0-1
- The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1;
- Adequate organ and bone marrow function, meeting the following definitions:
Key exclusion criteria (11 listed)
- A history of fistula caused by primary tumor invasion;
- Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization);
- Known intolerance or resistance to chemotherapy specified in the trial protocol;
- have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy);
- Patients with active autoimmune disease or a history of autoimmune disease that may relapse, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
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 |
|---|---|---|
| TislelizumabParticipants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks | Drug | Tislelizumab combined with chemothapy |
| Albumin paclitaxelParticipants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks | Drug | Tislelizumab combined with chemothapy |
| NedaplatinParticipants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks | Drug | Tislelizumab combined with chemothapy |
| radiotherapy50-60Gy/25-30f | Radiation | Tislelizumab combined with chemothapy |
Primary outcome
progression free survival
Time frame: up to 24 months
Time from enrollment to the onset of disease progression or death
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: every 6 weeks （up to 24 months）
Overall survival (OS)
Time frame: every 3 months (up to 24 months)
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 7 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Albumin paclitaxel and Nedaplatin in people with Immunotherapy Esophagus Cancer, run by Fuzhou General 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 10 inclusion and 11 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 7 Feb 2024. 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.
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 Fu zhi chao, Doctor of Medicine (13774562945 ext. 86, fauster1112@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: 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 7 Feb 2024.