Valid MeSH ConditionsPhase 2NCT07709533
An Umbrella-designed Prospective Multicenter Randomized Open-label Superiority Trial Evaluating Multi-biomarker-guided Precision Therapy for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor in people with Valid MeSH Conditions, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, multicenter, randomized, open-label, umbrella superiority clinical trial for patients with advanced metastatic esophageal squamous cell carcinoma who have not received prior anti-tumor treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Valid MeSH Conditions
- What is being tested?
- Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 347 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2026to 30 Jun 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years (calculated on the date of signing the informed consent form);
- Patients with metastatic esophageal squamous cell carcinoma (ESCC) confirmed by histopathology or cytology;
- Treatment-naïve patients with no prior anti-tumor therapy;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, with an expected survival of more than 3 months;
- Judged by the investigator to be suitable for first-line chemotherapy;
- Presence of at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1);
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- Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study period and for 6 months after the end of study treatment; they must have a negative serum or urine pregnancy test within 7 days prior to enrollment and shall not be breastfeeding. Male patients must agree to use effective contraception throughout the study period and for 6 months after the end of study treatment.
- Version: 1.0, Version Date: March 18, 2026
- Voluntarily participate in this study and provide written informed consent.
Who cannot join
- Brain metastases with symptoms or symptom control duration less than 2 months;
- History of or concurrent other malignant tumors within the past 3 years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):
- Absolute Neutrophil Count (ANC) < 1.5 × 10⁹/L;
- Platelet count < 100 × 10⁹/L;
- Hemoglobin < 90 g/L.
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- Hepatic abnormalities:
- Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) or Alkaline Phosphatase (ALP) > 2.5 × Upper Limit of Normal (ULN) in patients without liver metastases; ALT, AST or ALP > 5 × ULN in patients with liver metastases;
- Serum total bilirubin > 1.5 × ULN (> 3 × ULN for patients with Gilbert's syndrome);
- Decompensated liver cirrhosis (Child-Pugh liver function grade B or C);
- Positive Hepatitis B Surface Antigen (HBsAg) with Hepatitis B Virus (HBV) DNA load ≥ 2000 IU/mL. Patients with positive HBsAg and HBV DNA load < 2000 IU/mL must receive anti-HBV therapy for at least 2 weeks prior to the first study drug administration;
- Positive Hepatitis C Virus (HCV) antibody with detectable HCV RNA.
- Renal abnormalities:
- Serum creatinine > 1.5 × ULN or estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula;
- Urinalysis showing urine protein ≥ ++, confirmed with 24-hour urinary protein quantification > 1.0 g;
- Renal failure requiring hemodialysis or peritoneal dialysis;
- Medical history of nephrotic syndrome.
- Bleeding risks:
- Abnormal coagulation function: Activated Partial Thromboplastin Time (APTT) or Thrombin Time (TT) > 1.5 × ULN, or International Normalized Ratio (INR) > 1.5 (> 2.5 for subjects receiving anticoagulant therapy);
- History of hemorrhage (hemoptysis), coagulopathy, or ongoing use of warfarin, aspirin, low-molecular-weight heparin and other antiplatelet drugs (except prophylactic aspirin at a dose ≤ 100 mg/day);
- Any signs or history of bleeding diathesis regardless of severity;
- Active gastrointestinal bleeding defined as hematemesis, hematochezia or melena within the past 3 months without evidence of resolution confirmed by gastroscopy or colonoscopy;
- Any Grade ≥ 3 bleeding event per CTCAE occurring within 4 weeks prior to the first study drug administration.
- Version: 1.0, Version Date: March 18, 2026
- Cardiovascular and cerebrovascular abnormalities:
- Subjects with any of the following conditions within 12 months before the first study drug administration: grade ≥ II myocardial ischemia or myocardial infarction, arrhythmia, grade ≥ III cardiac insufficiency, uncontrolled angina, coronary/peripheral artery bypass graft surgery, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, etc.;
- Deep vein thrombosis or pulmonary embolism occurring within 6 months before the first study drug administration;
- Left Ventricular Ejection Fraction (LVEF) < 50% assessed by Doppler echocardiography;
- Average Fridericia-corrected QT interval (QTcF) (from at least 3 consecutive electrocardiograms): ≥ 450 ms for male patients, ≥ 470 ms for female patients;
- Uncontrolled hypertension refractory to medication (systolic blood pressure ≥ 150 mmHg and diastolic blood pressure ≥ 100 mmHg recorded in at least two measurements).
- History of immunodeficiency:
- Confirmed Human Immunodeficiency Virus (HIV) infection;
- Other acquired or congenital immunodeficiency disorders;
- Scheduled or prior solid organ transplantation, hematopoietic stem cell transplantation within 60 days before the first study drug administration, or significant graft-versus-host disease;
- Patients requiring immunosuppressants, systemic or absorbable local hormonal therapy for immunosuppressive purposes that must be continued within 7 days before the first study drug administration (excluding daily glucocorticoid dose < 10 mg prednisone or equivalent steroids).
- Active or uncontrolled severe infection (Grade ≥ 2 per CTCAE);
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage (judged by the investigator);
- Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody, or any other antibodies targeting T cell co-stimulatory or checkpoint pathways (e.g., OX40, CD137, etc.);
- Complicated with severe or poorly controlled diseases judged by the investigator to carry substantial risks for study participation (e.g., poorly controlled diabetes with screening fasting plasma glucose (FPG) > 10 mmol/L);
- Participation in another clinical trial of anti-tumor agents within 28 days prior to screening.
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
Sub-i
Guangdong, GUANGZHOU, 510000
Luo huiyan Luohuiyan, 02087343560, luohy@sysucc.org.cn
About this study
Official title: A Prospective, Multicenter, Randomized, Open-label, Superiority Clinical Trial With an Umbrella Trial Design Framework to Evaluate the Efficacy of a Precision Treatment Strategy Guided by Multiple Biomarkers in the First-line Therapy of Advanced Esophageal Squamous Cell Carcinoma
This is a prospective, multicenter, randomized, open-label, umbrella superiority clinical trial for patients with advanced metastatic esophageal squamous cell carcinoma who have not received prior anti-tumor treatment.
All eligible participants will be randomly assigned into two cohorts: Cohort A (standard treatment group) and Cohort B (biomarker-guided precision treatment group).
Read more
Patients in Cohort A will receive first-line standard therapy consisting of TP chemotherapy plus PD-1 inhibitor.
All patients in Cohort B will first complete three biomarker tests, then be divided into 4 sub-groups based on biomarker results to receive biomarker-directed additional treatment combined with the same standard backbone therapy. Participants with all negative biomarkers or failed biomarker testing will receive the identical standard treatment as Cohort A.
The primary objective is to compare the survival benefit between biomarker-guided multi-strategy precision therapy and conventional standard first-line treatment.
Read the detailed description
This umbrella-design randomized controlled trial enrolls treatment-naïve patients aged 18-75 years with histologically confirmed metastatic esophageal squamous cell carcinoma with measurable lesions per RECIST 1.1 and ECOG PS 0-1.
Subjects are randomized at a 1:3.75 ratio to standard first-line TP+PD-1 treatment (Cohort A) or biomarker-stratified experimental treatment (Cohort B). Three predictive biomarkers including plasma TGF-β, circulating metabolite score and blood Lactobacillus level will be detected at screening for Cohort B patients to allocate targeted add-on interventions.
Key exclusion criteria include uncontrolled brain metastasis, severe organ dysfunction, active severe infection, prior immune checkpointInhibitor treatment and bleeding disorders with a high risk of hemorrhage. The main efficacy endpoint is progression-free survival; secondary endpoints include objective response rate, disease control rate, overall survival, safety and so on.
- Conditions
- Valid MeSH Conditions
- Being tested
- Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor, Retlirafusp alfa / Indole-3-carbinol + Black garlic fermentation extract / Lactobacillus rhamnosus / Placebo + Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor
- Keywords
- Esophageal squamous cell carcinoma, TGF-β
- 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.
Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitorDrug
Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor
Retlirafusp alfa / Indole-3-carbinol + Black garlic fermentation extract / Lactobacillus rhamnosus / Placebo + Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitorDrug
Group B1 (TGF-guided intervention, n=73): Plasma TGF-B ELISA levels positive, combined with Retlirafusp alfa on top of chemo-immunotherapy backbone; Group B2 (metabolite-guided intervention, n=73): Did not meet TGF-β positivity, combined with indole-3-carbinol and black garlic fermentation extract on top of chemo-immunotherapy backbone; Group B3 (Lactobacillus-guided intervention, n=73): Those who don't meet B1 or B2 criteria but have positive blood Lactobacillus qPCR levels, combined with Lactobacillus rhamnosus on top of chemo-immunotherapy backbone; Group B4 (Screening failed group, n=55): All three biomarker tests are negative or testing failed due to technical reasons, receive the same conventional treatment as cohort A
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Active comparator | Participants in this arm will receive standard first-line treatment for advanced esophageal squamous cell carcinoma, consisting of TP chemotherapy plus a PD-1 inhibitor.
TP regimen refers to Nab-Paclitaxel combined with cisplatin. Receives: Drug: Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor |
| Experimental Arm | Experimental | Subgroup B1 (TGF-β-guided Intervention):
Patients with positive plasma TGF-β levels detected by ELISA; they will receive Retlirafusp alfa combined with chemo-immunotherapy backbone.
Subgroup B2 (Metabolite-guided Intervention):
Patients who do not meet the criteria for Subgroup B1 and have positive plasma metabolite predictive score; they will receive indole-3-carbinol plus fermented black garlic extract combined with chemo-immunotherapy backbone.
Subgroup B3 (Lactobacillus-guided Intervention):
Patients who do not meet the criteria for Subgroup B1 or B2 and have positive blood Lactobacillus levels measured by qPCR; they will receive Lactobacillus rhamnosus combined with chemo-immunotherapy backbone.
Subgroup B4 (Screening Failure Subgroup):
Patients with negative results for all three biomarkers due to technical issues; they will receive the same conventional treatment as Cohort A. Receives: Drug: Retlirafusp alfa / Indole-3-carbinol + Black garlic fermentation extract / Lactobacillus rhamnosus / Placebo + Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: Up to 2 Years
Secondary outcomes (7)
Objective Response Rate (ORR)
Measured: Up to 2 Years
Disease Control Rate (DCR)
Measured: up to 2 years
Duration of Response (DOR)
Measured: up to 2 years
Overall Survival (OS)
Measured: up to 2 years
quality of life score
Measured: up to 2 years
incidence and severity of adverse events (AEs)
Measured: up to 2 years
serious adverse events (SAEs)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start7 Jul 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valid MeSH ConditionsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 347 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709533
- Sponsor's protocol ID
- SL-B2025-677-01
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study ProtocolStatistical Analysis Plan (SAP)Informed Consent Form (ICF)
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Open-label, Superiority Clinical Trial With an Umbrella Trial Design Framework to Evaluate the Efficacy of a Precision Treatment Strategy Guided by Multiple Biomarkers in the First-line Therapy of Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07709533
- Acronym / sponsor ID
- SL-B2025-677-01
- Conditions
- Valid MeSH Conditions
- Keywords
- Esophageal squamous cell carcinoma, TGF-β
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 347 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 16 Jul 2026 (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 is a prospective, multicenter, randomized, open-label, umbrella superiority clinical trial for patients with advanced metastatic esophageal squamous cell carcinoma who have not received prior anti-tumor treatment.
All eligible participants will be randomly assigned into two cohorts: Cohort A (standard treatment group) and Cohort B (biomarker-guided precision treatment group).
Patients in Cohort A will receive first-line standard therapy consisting of TP chemotherapy plus PD-1 inhibitor.
All patients in Cohort B will first complete three biomarker tests, then be divided into 4 sub-groups based on biomarker results to receive biomarker-directed additional treatment combined with the same standard backbone therapy. Participants with all negative biomarkers or failed biomarker testing will receive the identical standard treatment as Cohort A.
The primary objective is to compare the survival benefit between biomarker-guided multi-strategy precision therapy and conventional standard first-line treatment.
Detailed description
This umbrella-design randomized controlled trial enrolls treatment-naïve patients aged 18-75 years with histologically confirmed metastatic esophageal squamous cell carcinoma with measurable lesions per RECIST 1.1 and ECOG PS 0-1.
Subjects are randomized at a 1:3.75 ratio to standard first-line TP+PD-1 treatment (Cohort A) or biomarker-stratified experimental treatment (Cohort B). Three predictive biomarkers including plasma TGF-β, circulating metabolite score and blood Lactobacillus level will be detected at screening for Cohort B patients to allocate targeted add-on interventions.
Key exclusion criteria include uncontrolled brain metastasis, severe organ dysfunction, active severe infection, prior immune checkpointInhibitor treatment and bleeding disorders with a high risk of hemorrhage. The main efficacy endpoint is progression-free survival; secondary endpoints include objective response rate, disease control rate, overall survival, safety and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Active comparator | Drug: Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitorParticipants in this arm will receive standard first-line treatment for advanced esophageal squamous cell carcinoma, consisting of TP chemotherapy plus a PD-1 inhibitor. TP regimen refers to Nab-Paclitaxel combined with cisplatin. |
| Experimental Arm | Experimental | Drug: Retlirafusp alfa / Indole-3-carbinol + Black garlic fermentation extract / Lactobacillus rhamnosus / Placebo + Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitorSubgroup B1 (TGF-β-guided Intervention): Patients with positive plasma TGF-β levels detected by ELISA; they will receive Retlirafusp alfa combined with chemo-immunotherapy backbone. Subgroup B2 (Metabolite-guided Intervention): Patients who do not meet the criteria for Subgroup B1 and have positive plasma metabolite predictive score; they will receive indole-3-carbinol plus fermented black garlic extract combined with chemo-immunotherapy backbone. Subgroup B3 (Lactobacillus-guided Intervention): Patients who do not meet the criteria for Subgroup B1 or B2 and have positive blood Lactobacillus levels measured by qPCR; they will receive Lactobacillus rhamnosus combined with chemo-immunotherapy backbone. Subgroup B4 (Screening Failure Subgroup): Patients with negative results for all three biomarkers due to technical issues; they will receive the same conventional treatment as Cohort A. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged between 18 and 75 years (calculated on the date of signing the informed consent form);
- Patients with metastatic esophageal squamous cell carcinoma (ESCC) confirmed by histopathology or cytology;
- Treatment-naïve patients with no prior anti-tumor therapy;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, with an expected survival of more than 3 months;
- Judged by the investigator to be suitable for first-line chemotherapy;
Key exclusion criteria (40 listed)
- Brain metastases with symptoms or symptom control duration less than 2 months;
- History of or concurrent other malignant tumors within the past 3 years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):
- Hepatic abnormalities:
- Renal abnormalities:
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 |
|---|---|---|
| Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitorPaclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor | Drug | Conventional Therapy |
| Retlirafusp alfa / Indole-3-carbinol + Black garlic fermentation extract / Lactobacillus rhamnosus / Placebo + Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitorGroup B1 (TGF-guided intervention, n=73): Plasma TGF-B ELISA levels positive, combined with Retlirafusp alfa on top of chemo-immunotherapy backbone; Group B2 (metabolite-guided intervention, n=73): Did not meet TGF-β positivity, combined with indole-3-carbinol and black garlic fermentation extract on top of chemo-immunotherapy backbone; Group B3 (Lactobacillus-guided intervention, n=73): Those who don't meet B1 or B2 criteria but have positive blood Lactobacillus qPCR levels, combined with Lactobacillus rhamnosus on top of chemo-immunotherapy backbone; Group B4 (Screening failed group, n=55): All three biomarker tests are negative or testing failed due to technical reasons, receive the same conventional treatment as cohort A | Drug | Experimental Arm |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 2 Years
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 2 Years
Disease Control Rate (DCR)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 years
quality of life score
Time frame: up to 2 years
incidence and severity of adverse events (AEs)
Time frame: up to 2 years
serious adverse events (SAEs)
Time frame: up to 2 years
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 16 Jul 2026.
- Individual participant dataSharing planned: Yes. Study ProtocolStatistical Analysis Plan (SAP)Informed Consent Form (ICF)
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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 Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor in people with Valid MeSH Conditions, run by Sun Yat-sen University 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 9 inclusion and 40 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 16 Jul 2026. 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 XU ruihua Xuruihua (020-87342479, luohy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 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 16 Jul 2026.