Esophageal Squamous Cell Carcinoma (ESCC)PKU-ESCCNCT07152535
Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor
An observational study of Esophageal Squamous Cell Carcinoma (ESCC), run by Peking University Cancer Hospital & Institute.
Trial summary
This prospective observational study (PKU-ESCC-Monitor) aims to characterize the dynamic evolution of esophageal squamous cell carcinoma (ESCC) using integrated multi-omics, including tissue genomics, ctDNA, imaging features, immune profiling and microbiome. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jul 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (18-79 years) with histologically confirmed esophageal squamous cell carcinoma (ESCC) treated at Peking University Cancer Hospital and participating centers in China. Two prospective cohorts: (1) peri-operative patients who complete standard neoadjuvant therapy and undergo transthoracic esophagectomy; (2) unresectable/advanced ESCC receiving standard-of-care first-line immunotherapy. ECOG 0-1. Tumor tissue (biopsy or surgical; archived FFPE slides acceptable if fresh tissue is unavailable) and serial blood are collected for multi-omics analyses. Key exclusions include prior systemic therapy for advanced disease (except neoadjuvant in the peri-operative cohort), other active malignancies within 5 years (allowing non-melanoma skin and in-situ cervical cancer), inadequate clinical information, or investigator-assessed unsuitability.
Who may be able to join
- Peri-operative cohort:
- Age ≥18 and <80 years; ECOG 0-1.
- Histologically confirmed ESCC.
- Completed standard neoadjuvant therapy and planned/underwent 4.transthoracic esophagectomy with routine surgical specimens available.
- 5.Able to provide clinical course/outcomes and comply with follow-up at participating sites.
- Advanced first-line immunotherapy cohort:
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- Age ≥18 and <80 years; ECOG 0-1.
- Histologically confirmed ESCC, or highly suspected by endoscopy/imaging when surgery is not feasible.
- No prior systemic anti-cancer therapy for advanced disease; archived FFPE slides (3-5 µm, 5-8 slides) acceptable if fresh tissue unavailable.
- Able to provide clinical information and comply with follow-up.
Who cannot join
- Prior anti-cancer therapy (except standard neoadjuvant therapy in the peri-operative cohort).
- Other malignancy within 5 years (exceptions: non-melanoma skin cancer, in-situ melanoma, in-situ cervical cancer).
- Inadequate clinical information.
- Known infection with HIV, HBV, HCV, or syphilis.
- Pre-operative imaging indicates insufficient tumor tissue (no visible target region) for study procedures.
- Any condition deemed by investigators to make the patient unsuitable.
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 prospective observational study (PKU-ESCC-Monitor) aims to characterize the dynamic evolution of esophageal squamous cell carcinoma (ESCC) using integrated multi-omics, including tissue genomics, ctDNA, imaging features, immune profiling and microbiome. Two cohorts will be followed: a peri-operative cohort after standard neoadjuvant therapy and surgery, and an advanced cohort receiving first-line immunotherapy. Clinical outcomes (DFS/PFS/OS) and biomarker dynamics will be analyzed to improve risk stratification and response prediction.
Read the detailed description
The study integrates clinical data with multi-omics (tumor tissue, surgical specimens, archived FFPE slides where applicable, serial blood for ctDNA and cytokines such as IL-6/IL-8, and exploratory immune/microbiome assessments). Patients are followed monthly or per routine visits up to 36-60 months. Analyses include RECIST 1.1-based responses (ORR, DCR, TTR, DOR), survival endpoints, and biomarker-clinical modeling to delineate ESCC evolutionary patterns and treatment response.
- Keywords
- ESCC, Multi-omics, ctDNA, Immunotherapy, Neoadjuvant Therapy, Prospective Cohort, Biomarkers
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Peri-operative ESCC Cohort | Patients with histologically confirmed ESCC who complete standard neoadjuvant therapy and undergo transthoracic esophagectomy. Study assigns no treatment; care is per treating physicians. Study procedures include collection of tumor tissue/surgical specimens or archived FFPE slides and serial blood for ctDNA/cytokines, plus prospective follow-up of clinical outcomes. | |
| Advanced ESCC First-line Immunotherapy Cohort | Patients with unresectable/advanced ESCC receiving standard-of-care first-line immunotherapy at participating centers. No assigned intervention by the study; all treatments are per routine practice. Study procedures include tumor biopsy or archived FFPE slides and serial blood for ctDNA/cytokines, with prospective follow-up for responses and survival. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
peri-operative cohort; time from study registration to first ESCC recurrence or death from any cause; patients alive without recurrence are censored at last contact.
Measured: up to 60 months
Progression-Free Survival (PFS)
advanced cohort;time from start of first-line therapy to first documented disease progression per RECIST 1.1 or death.
Measured: up to 36 months
Overall Survival (OS)
time from study registration to death from any cause.
Measured: up to 60 months
Secondary outcomes (4)
Time to Response (TTR)
time from study registration to first ESCC recurrence or death from any cause; patients alive without recurrence are censored at last contact.
Measured: up to 60 months
Objective Response Rate (ORR)
up to 24 months
Measured: best overall response up to 24 months; proportion with CR/PR by RECIST 1.1.
Disease Control Rate (DCR)
up to 24 months
Measured: up to 24 months; proportion with CR/PR/SD by RECIST 1.1.
Biomarker Analyses
exploratory associations for PD-L1, HER2, EGFR, ctDNA dynamics, IL-6/IL-8 and other immune/microbiome markers with outcomes.
Measured: baseline to 36-60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (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 Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152535
- Sponsor's protocol ID
- PKU-ESCC-0604
- Other IDs
- LGH2025236
- Acronym
- PKU-ESCC
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Monitoring of Dynamic Evolution in Esophageal Squamous Cell Carcinoma: PKU-ESCC-Monitor
- ClinicalTrials.gov ID
- NCT07152535
- Acronym / sponsor ID
- PKU-ESCC / PKU-ESCC-0604
- Keywords
- ESCC, Multi-omics, ctDNA, Immunotherapy, Neoadjuvant Therapy, Prospective Cohort, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 3 Sep 2025 (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 prospective observational study (PKU-ESCC-Monitor) aims to characterize the dynamic evolution of esophageal squamous cell carcinoma (ESCC) using integrated multi-omics, including tissue genomics, ctDNA, imaging features, immune profiling and microbiome. Two cohorts will be followed: a peri-operative cohort after standard neoadjuvant therapy and surgery, and an advanced cohort receiving first-line immunotherapy. Clinical outcomes (DFS/PFS/OS) and biomarker dynamics will be analyzed to improve risk stratification and response prediction.
Detailed description
The study integrates clinical data with multi-omics (tumor tissue, surgical specimens, archived FFPE slides where applicable, serial blood for ctDNA and cytokines such as IL-6/IL-8, and exploratory immune/microbiome assessments). Patients are followed monthly or per routine visits up to 36-60 months. Analyses include RECIST 1.1-based responses (ORR, DCR, TTR, DOR), survival endpoints, and biomarker-clinical modeling to delineate ESCC evolutionary patterns and treatment response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-operative ESCC Cohort | – | –Patients with histologically confirmed ESCC who complete standard neoadjuvant therapy and undergo transthoracic esophagectomy. Study assigns no treatment; care is per treating physicians. Study procedures include collection of tumor tissue/surgical specimens or archived FFPE slides and serial blood for ctDNA/cytokines, plus prospective follow-up of clinical outcomes. |
| Advanced ESCC First-line Immunotherapy Cohort | – | –Patients with unresectable/advanced ESCC receiving standard-of-care first-line immunotherapy at participating centers. No assigned intervention by the study; all treatments are per routine practice. Study procedures include tumor biopsy or archived FFPE slides and serial blood for ctDNA/cytokines, with prospective follow-up for responses and survival. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18-79 years) with histologically confirmed esophageal squamous cell carcinoma (ESCC) treated at Peking University Cancer Hospital and participating centers in China. Two prospective cohorts: (1) peri-operative patients who complete standard neoadjuvant therapy and undergo transthoracic esophagectomy; (2) unresectable/advanced ESCC receiving standard-of-care first-line immunotherapy. ECOG 0-1. Tumor tissue (biopsy or surgical; archived FFPE slides acceptable if fresh tissue is unavailable) and serial blood are collected for multi-omics analyses. Key exclusions include prior systemic therapy for advanced disease (except neoadjuvant in the peri-operative cohort), other active malignancies within 5 years (allowing non-melanoma skin and in-situ cervical cancer), inadequate clinical information, or investigator-assessed unsuitability.
Key inclusion criteria (10 listed)
- Age ≥18 and <80 years; ECOG 0-1.
- Histologically confirmed ESCC.
- Completed standard neoadjuvant therapy and planned/underwent 4.transthoracic esophagectomy with routine surgical specimens available.
- 5.Able to provide clinical course/outcomes and comply with follow-up at participating sites.
- Age ≥18 and <80 years; ECOG 0-1.
Key exclusion criteria (6 listed)
- Prior anti-cancer therapy (except standard neoadjuvant therapy in the peri-operative cohort).
- Other malignancy within 5 years (exceptions: non-melanoma skin cancer, in-situ melanoma, in-situ cervical cancer).
- Inadequate clinical information.
- Known infection with HIV, HBV, HCV, or syphilis.
- Pre-operative imaging indicates insufficient tumor tissue (no visible target region) for study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-Free Survival (DFS)
Time frame: up to 60 months
peri-operative cohort; time from study registration to first ESCC recurrence or death from any cause; patients alive without recurrence are censored at last contact.
Progression-Free Survival (PFS)
Time frame: up to 36 months
advanced cohort;time from start of first-line therapy to first documented disease progression per RECIST 1.1 or death.
Overall Survival (OS)
Time frame: up to 60 months
time from study registration to death from any cause.
4 secondary outcomes
Time to Response (TTR)
Time frame: up to 60 months
Objective Response Rate (ORR)
Time frame: best overall response up to 24 months; proportion with CR/PR by RECIST 1.1.
Disease Control Rate (DCR)
Time frame: up to 24 months; proportion with CR/PR/SD by RECIST 1.1.
Biomarker Analyses
Time frame: baseline to 36-60 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 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Esophageal Squamous Cell Carcinoma (ESCC), run by Peking University Cancer Hospital & Institute.
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 6 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 3 Sep 2025. 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.
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 Zhihao Lu (+85201088196561, pppeirain@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: up to 60 months). The study lists 3 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 3 Sep 2025.