Esophagus CancerPhase 2NCT05807542
Neoadjuvant Immunotherapy Combined With Chemotherapy in Patients With Locally Advanced ESCC
A Phase 2 study testing Tislelizumab, Paclitaxel-albumin and Carboplatin in people with Esophagus Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Prediction for pCR After Neoadjuvant Immunotherapy Combined With Chemotherapy Using Single-Cell RNA Sequencing in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Tislelizumab, Paclitaxel-albumin and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Apr 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
- Age 18-75 years ;
- Initially diagnosed patients with stage T2-4aN0-1M0 esophageal squamous cell carcinoma;
- No chemotherapy or any other antitumor therapy was used before inclusion
- ECOG score 0-1;
- Life expectancy is greater than 3 months;
- The patient has no indication for emergency surgery；
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- No immediate childbearing requirement；
- The main organs function well, and the examination indicators meet the following requirements:
- Blood routine examination:
- Hemoglobin ≥90 g/L (no blood transfusion within 14 days);
- Neutrophil count ≥1.5×109/L;
- Platelet count ≥75×109/L; ii. Biochemical examination: iii. Total bilirubin ≤1.5×ULN (upper limit of normal); iv. Serum alanine aminotransferase (ALT) or serum alanine oxalacetic aminotransferase (AST) ≤ 2.5×ULN; v. Endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula);
- Sign informed consent;
- The compliance was good, and the family members agreed to cooperate with the survival follow-up.
Who cannot join
- Pregnant or nursing women；
- Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and cervical carcinoma in situ；
- Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as determined by the investigator, may prevent the signing of informed consent or affect the patient's adherence to medication use；
- Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases；
- Allergic to any investigational drug ingredient；
- Any bleeding event with a severe grade of 3 or above CTCAE4.0 occurring within 4 weeks prior to screening;
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- Patients with hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg) who are not well controlled by single antihypertensive medication;History of unstable angina pectoris;Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening;Arrhythmias (including QTcF: male ≥450 ms) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade ≥II cardiac insufficiency;
- Long-term unhealed wounds or incomplete healing fractures;
- Previous history of organ transplantation;
- Imaging shows that the tumor has invaded important blood vessels, or the investigator determines that the patient's tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment;
- Patients with abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L) and bleeding tendency (14 days before randomization must meet the requirement that INR is within the normal range without the use of anticoagulants);Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogities;Low doses of warfarin (1 mg orally, once daily) or low doses of aspirin (up to 100 mg daily) are permitted for prophylactic purposes if INR ≤ 1.5;
- Occurrence of arteriovenous thrombosis within one year prior to screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization during previous chemotherapy and determined to be cured by researchers), pulmonary embolism, etc.;
- Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;
- A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study.
- Patients who did not meet the inclusion criteria, or who were considered unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction for pCR After Neoadjuvant Immunotherapy Combined With Chemotherapy Using Single-Cell RNA Sequencing in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC) : A Single-Arm Phase II Clinical Trial
Prediction for pCR After Neoadjuvant Immunotherapy Combined With Chemotherapy Using Single-Cell RNA Sequencing in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
- Conditions
- Esophagus Cancer
- Being tested
- Tislelizumab, Paclitaxel-albumin, Carboplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 21 days.
Paclitaxel-albuminDrug
Paclitaxel-albumin will be administered on day 1 of each cycle at 260mg/m2 once every 21 days.
CarboplatinDrug
carboplatin will be administered on day 1 of each cycle at AUC=5 once every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with chemotherapy | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Paclitaxel-albumin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Measured: 4 weeks after surgery
Secondary outcomes (2)
Major pathological response
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Measured: 4 weeks after surgery
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Measured: At the end of Cycle 3 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Mar 2022
- Primary completion30 Sep 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807542
- Sponsor's protocol ID
- SEEK-01
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2023
- Last updated
- 16 May 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction for pCR After Neoadjuvant Immunotherapy Combined With Chemotherapy Using Single-Cell RNA Sequencing in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC) : A Single-Arm Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT05807542
- Acronym / sponsor ID
- SEEK-01
- Conditions
- Esophagus Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 11 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.
Prediction for pCR After Neoadjuvant Immunotherapy Combined With Chemotherapy Using Single-Cell RNA Sequencing in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
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 chemotherapy | Experimental | Drug: Tislelizumab, Drug: Paclitaxel-albumin, Drug: Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18-75 years ;
- Initially diagnosed patients with stage T2-4aN0-1M0 esophageal squamous cell carcinoma;
- No chemotherapy or any other antitumor therapy was used before inclusion
- ECOG score 0-1;
- Life expectancy is greater than 3 months;
Key exclusion criteria (16 listed)
- Pregnant or nursing women；
- Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and cervical carcinoma in situ；
- Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as determined by the investigator, may prevent the signing of informed consent or affect the patient's adherence to medication use；
- Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases；
- Allergic to any investigational drug ingredient；
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 |
|---|---|---|
| TislelizumabTislelizumab will be administered on day 1 of each cycle at 200mg once every 21 days. | Drug | Tislelizumab combined with chemotherapy |
| Paclitaxel-albuminPaclitaxel-albumin will be administered on day 1 of each cycle at 260mg/m2 once every 21 days. | Drug | Tislelizumab combined with chemotherapy |
| Carboplatincarboplatin will be administered on day 1 of each cycle at AUC=5 once every 21 days. | Drug | Tislelizumab combined with chemotherapy |
Primary outcome
Pathological complete response
Time frame: 4 weeks after surgery
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
2 secondary outcomes
Major pathological response
Time frame: 4 weeks after surgery
Objective Response Rate (ORR)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, Paclitaxel-albumin and Carboplatin in people with Esophagus Cancer, run by Shanghai Zhongshan 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 14 inclusion and 16 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: finished, as of the sponsor's last update on 16 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: 4 weeks after surgery). 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 16 May 2024.