Esophageal Squamous Cell CarcinomactDNANCT06103890
Dynamic ctDNA Monitoring in Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This study is a prospective, multicenter, open-label, observational cohort study. The primary endpoint is pathological complete response (pCR), and the secondary endpoints include R0 resection rate, ctDNA clearance rate, major pathological response (MPR), recurrence-free survival (RFS), and overall survival (OS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2023to 31 Jul 2025
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage II-III (potentially) operable esophageal squamous cell carcinoma
Who may be able to join
- Age between 18 and 70 years, regardless of gender.
- Patients with histologically confirmed clinical stage II-III thoracic esophageal squamous cell carcinoma.
- Neck enhanced CT scan showing no suspicious lymph node metastasis in the neck; no systemic metastasis detected by imaging examination.
- Expected to achieve R0 resection.
- ECOG performance status of 0-1.
- No prior anti-tumor treatment for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy, and immunotherapy.
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- Measurable lesions (according to RECIST v1.1 criteria).
- Preoperative evaluation of organ function shows no contraindications for surgery.
- Laboratory tests confirm good bone marrow, liver, kidney function, and coagulation function.
- Able to provide informed consent and willing to cooperate with clinical follow-up.
- Willing to provide peripheral blood samples for testing, as well as the patient's medical history, current treatment information, imaging studies, and tumor marker data, and willing to use the testing data for further scientific research, clinical diagnosis and treatment, and commercial product development.
Who cannot join
- Unable to provide a sufficient amount of tissue samples/blood samples required for the study before treatment.
- Patient refuses to undergo MRD testing.
- History of malignancies other than esophageal cancer within the past 5 years (excluding cured localized tumors, such as cervical carcinoma in situ, basal cell carcinoma, and prostate carcinoma in situ; patients with prostate cancer who have received hormone therapy and achieved disease-free survival for more than 5 years are not excluded).
- History of gastrointestinal bleeding within the past 6 months, or presence of coagulation abnormalities at enrollment, or currently receiving thrombolytic or anticoagulant therapy, indicating a high risk of bleeding.
- Severe cardiovascular or cerebrovascular diseases.
- History of interstitial lung disease or active pneumonia requiring steroid treatment at enrollment.
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- Active tuberculosis at enrollment or received anti-tuberculosis treatment within the past year.
- Bronchial asthma requiring intermittent use of bronchodilators or other medical interventions at enrollment.
- Presence of systemic infectious diseases requiring systemic treatment within the past 4 weeks at enrollment.
- Severe unhealed wounds, active ulcers, or untreated fractures at enrollment.
- Presence of other non-surgical conditions.
- Previous surgeries that prevent the use of gastric conduit for esophageal reconstruction.
- Severe allergic reactions to chemotherapy drugs (such as paclitaxel, albumin-bound paclitaxel, cisplatin, or carboplatin) or any monoclonal antibody.
- History of organ transplantation.
- Other conditions deemed unsuitable for participation in this study according to the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Ziqiang Tian, MD, 18531118000, tianzq1026@163.com
Huilai Lv, MD, 13931135605, lvhl2288@163.com
About this study
Official title: A Study on Dynamic Monitoring of ctDNA in Neoadjuvant Therapy With Cetuximab Combined With Albumin-bound Paclitaxel and Nedaplatin for Esophageal Squamous Cell Carcinoma
This study is a prospective, multicenter, open-label, observational cohort study. The primary endpoint is pathological complete response (pCR), and the secondary endpoints include R0 resection rate, ctDNA clearance rate, major pathological response (MPR), recurrence-free survival (RFS), and overall survival (OS). Chinese patients with esophageal squamous cell carcinoma who are eligible for surgical resection will receive neoadjuvant therapy with cetuximab combined with albumin-bound paclitaxel and nedaplatin. Personalized ctDNA monitoring will be conducted at multiple time points, including before neoadjuvant therapy, during therapy, preoperatively, postoperatively, and during adjuvant therapy, to explore the clinical value of minimal residual disease (MRD) as a biomarker for assessing treatment efficacy, predicting recurrence risk, and evaluating prognosis in esophageal squamous cell carcinoma. This study aims to enroll 100 Chinese patients with stage II-III (potentially) resectable esophageal squamous cell carcinoma.
Read the detailed description
This study aims to enroll 100 Chinese patients with stage II-III (potentially) resectable esophageal squamous cell carcinoma.
Tumor tissue samples will be collected from the subjects before neoadjuvant therapy for whole-exome sequencing (WES). Based on the WES results, personalized ctDNA detection panels will be designed (referred to as panel 1) for blood-based multiplex PCR-NGS testing. Blood samples will be collected at baseline (T0), after the first cycle of treatment (T1), after the second cycle of treatment (T2), after the third cycle of treatment (T3), and after the fourth cycle of treatment (T4) for monitoring.
Intraoperative tumor tissue will be collected. For patients with tumor cell content ≥20%, WES will be performed, and a personalized ctDNA detection panel (referred to as panel 2) will be designed based on the WES results. For patients with tumor cell content <20%, panel 1 will continue to be used for blood-based multiplex PCR-NGS testing. Blood samples will be collected before surgery (T5), 3-7 days after surgery (T6), and during the adjuvant therapy period (T7-TN) for ctDNA monitoring. MRD monitoring will be conducted every 3-6 months during follow-up, with dynamic recurrence monitoring until radiological recurrence or the end of the study. The stable detection limit for ctDNA monitoring is 0.02%.
It is expected to complete enrollment within 1 year. Clinical and pathological data, such as performance status, imaging, and serum markers (e.g., CEA), will be collected during the clinical trial. Follow-up will be conducted for 24 months, and data on treatment regimens, recurrence-free survival (RFS), overall survival (OS), adverse events (AE), etc., will be collected. Continuous observation will be conducted for up to 3 years.
Bioinformatics analysis will be performed on the data to construct mutation profiles. Statistical analysis will be conducted to establish the correlation between ctDNA positivity, mutation characteristics, and prognostic indicators. The ctDNA data analysis results will be linked to clinical management to ultimately improve clinical care.
Treatment regimen: Neoadjuvant therapy with cetuximab combined with albumin-bound paclitaxel and nedaplatin for 2-4 cycles:
Albumin-bound paclitaxel: 400mg, IV, on day 1, every 3 weeks; Nedaplatin: 80 mg/m2, IV, every 3 weeks; Cetuximab: 200mg, IV, on day 1, every 3 weeks.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- neoadjuvant therapy, esophageal squamous cancer, ctDNA, immunochemotherapy, dynamic monitoring, biomarker
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pCR stands for pathological complete response. It refers to the absence of any detectable cancer cells in the tissue sample taken during surgery after neoadjuvant treatment.
Measured: Up to 1 year
Secondary outcomes (5)
R0 resection rate
The R0 resection rate refers to the rate of complete tumor removal without any residual tumor cells in the surgical specimen after neoadjuvant treatment.
Measured: Up to 1 year
ctDNA clearance rate
The ctDNA clearance rate refers to the extent of elimination of circulating tumor DNA (ctDNA) during neoadjuvant treatment. It is evaluated by comparing the levels of ctDNA before and after neoadjuvant therapy to assess the impact of treatment on the tumor.
Measured: Up to 1 year
MPR
MPR stands for Major Pathological Response. It refers to a significant reduction or disappearance of tumor cells in the surgical specimen after neoadjuvant therapy.
Measured: Up to 1 year
RFS
RFS stands for Recurrence-Free Survival. It refers to the length of time after curative surgery following neoadjuvant treatment during which a patient remains free from any signs or symptoms of cancer recurrence.
Measured: 3 years
OS
OS stands for Overall Survival. It refers to the length of time from the start of neoadjuvant treatment to the death of a patient from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start22 May 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2025 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Handan Central Hospital, Xingtai People's Hospital
- Responsible party
- Sponsor
- Investigators
- Ziqiang Tian, MD, Study chair, Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103890
- Sponsor's protocol ID
- NATEC
- Acronym
- ctDNA
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2023
- Last updated
- 27 Oct 2023
- 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Dynamic Monitoring of ctDNA in Neoadjuvant Therapy With Cetuximab Combined With Albumin-bound Paclitaxel and Nedaplatin for Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06103890
- Acronym / sponsor ID
- ctDNA / NATEC
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- neoadjuvant therapy, esophageal squamous cancer, ctDNA, immunochemotherapy, dynamic monitoring, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Collaborators
- Handan Central Hospital, Xingtai People's Hospital
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 27 Oct 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.
This study is a prospective, multicenter, open-label, observational cohort study. The primary endpoint is pathological complete response (pCR), and the secondary endpoints include R0 resection rate, ctDNA clearance rate, major pathological response (MPR), recurrence-free survival (RFS), and overall survival (OS). Chinese patients with esophageal squamous cell carcinoma who are eligible for surgical resection will receive neoadjuvant therapy with cetuximab combined with albumin-bound paclitaxel and nedaplatin. Personalized ctDNA monitoring will be conducted at multiple time points, including before neoadjuvant therapy, during therapy, preoperatively, postoperatively, and during adjuvant therapy, to explore the clinical value of minimal residual disease (MRD) as a biomarker for assessing treatment efficacy, predicting recurrence risk, and evaluating prognosis in esophageal squamous cell carcinoma. This study aims to enroll 100 Chinese patients with stage II-III (potentially) resectable esophageal squamous cell carcinoma.
Detailed description
This study aims to enroll 100 Chinese patients with stage II-III (potentially) resectable esophageal squamous cell carcinoma.
Tumor tissue samples will be collected from the subjects before neoadjuvant therapy for whole-exome sequencing (WES). Based on the WES results, personalized ctDNA detection panels will be designed (referred to as panel 1) for blood-based multiplex PCR-NGS testing. Blood samples will be collected at baseline (T0), after the first cycle of treatment (T1), after the second cycle of treatment (T2), after the third cycle of treatment (T3), and after the fourth cycle of treatment (T4) for monitoring.
Intraoperative tumor tissue will be collected. For patients with tumor cell content ≥20%, WES will be performed, and a personalized ctDNA detection panel (referred to as panel 2) will be designed based on the WES results. For patients with tumor cell content <20%, panel 1 will continue to be used for blood-based multiplex PCR-NGS testing. Blood samples will be collected before surgery (T5), 3-7 days after surgery (T6), and during the adjuvant therapy period (T7-TN) for ctDNA monitoring. MRD monitoring will be conducted every 3-6 months during follow-up, with dynamic recurrence monitoring until radiological recurrence or the end of the study. The stable detection limit for ctDNA monitoring is 0.02%.
It is expected to complete enrollment within 1 year. Clinical and pathological data, such as performance status, imaging, and serum markers (e.g., CEA), will be collected during the clinical trial. Follow-up will be conducted for 24 months, and data on treatment regimens, recurrence-free survival (RFS), overall survival (OS), adverse events (AE), etc., will be collected. Continuous observation will be conducted for up to 3 years.
Bioinformatics analysis will be performed on the data to construct mutation profiles. Statistical analysis will be conducted to establish the correlation between ctDNA positivity, mutation characteristics, and prognostic indicators. The ctDNA data analysis results will be linked to clinical management to ultimately improve clinical care.
Treatment regimen: Neoadjuvant therapy with cetuximab combined with albumin-bound paclitaxel and nedaplatin for 2-4 cycles:
Albumin-bound paclitaxel: 400mg, IV, on day 1, every 3 weeks; Nedaplatin: 80 mg/m2, IV, every 3 weeks; Cetuximab: 200mg, IV, on day 1, every 3 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage II-III (potentially) operable esophageal squamous cell carcinoma
Key inclusion criteria (11 listed)
- Age between 18 and 70 years, regardless of gender.
- Patients with histologically confirmed clinical stage II-III thoracic esophageal squamous cell carcinoma.
- Neck enhanced CT scan showing no suspicious lymph node metastasis in the neck; no systemic metastasis detected by imaging examination.
- Expected to achieve R0 resection.
- ECOG performance status of 0-1.
Key exclusion criteria (15 listed)
- Unable to provide a sufficient amount of tissue samples/blood samples required for the study before treatment.
- Patient refuses to undergo MRD testing.
- History of malignancies other than esophageal cancer within the past 5 years (excluding cured localized tumors, such as cervical carcinoma in situ, basal cell carcinoma, and prostate carcinoma in situ; patients with prostate cancer who have received hormone therapy and achieved disease-free survival for more than 5 years are not excluded).
- History of gastrointestinal bleeding within the past 6 months, or presence of coagulation abnormalities at enrollment, or currently receiving thrombolytic or anticoagulant therapy, indicating a high risk of bleeding.
- Severe cardiovascular or cerebrovascular diseases.
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
pCR
Time frame: Up to 1 year
pCR stands for pathological complete response. It refers to the absence of any detectable cancer cells in the tissue sample taken during surgery after neoadjuvant treatment.
5 secondary outcomes
R0 resection rate
Time frame: Up to 1 year
ctDNA clearance rate
Time frame: Up to 1 year
MPR
Time frame: Up to 1 year
RFS
Time frame: 3 years
OS
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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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.
Ziqiang Tian, MD study chair
Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth 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 11 inclusion and 15 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 27 Oct 2023. 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.
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 Ziqiang Tian, MD (18531118000, tianzq1026@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: Up to 1 year). 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 27 Oct 2023.