Esophageal CancerNCT06792786
A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring
A study testing Induction Immunochemotherapy in people with Esophageal Cancer and ctDNA, run by The Central Hospital of Lishui City at 2 sites in China.
Trial summary
Esophageal squamous cell carcinoma (ESCC) continues to exhibit high incidence and mortality rates in China, with the majority of patients diagnosed at middle to advanced stages. Concurrent chemoradiotherapy (CCRT) is the standard treatment for unresectable locally advanced ESCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, ctDNA
- What is being tested?
- Induction Immunochemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 10 Dec 2024to 30 Dec 2027
- Phase
- Interventional
- 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
- All subjects must sign an informed consent form before initiating any study-related procedures;
- All patients must be aged ≥18 years and ≤75 years;
- Histologically or cytologically confirmed esophageal cancer (squamous cell carcinoma);
- Clinical stage II-IVa, assessed by a surgeon as inoperable, or patient refusal of surgery;
- No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer;
- ECOG performance status of 0-1;
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- Laboratory test values within the following limits before the first dose of the investigational drug:
- Hematology: WBC ≥3.0×10⁹/L; ANC ≥1.5×10⁹/L; PLT ≥70×10⁹/L; HGB ≥9.0 g/dL;
- Liver function: AST ≤2.5×ULN; ALT ≤2.5×ULN;
- Renal function: Cr ≤1.5×ULN or CrCl ≥40 mL/min;
- Coagulation: INR ≤1.5, APTT ≤1.5×ULN;
- Other: Lipase ≤1.5×ULN, unless clinically/radiographically insignificant if lipase >1.5×ULN.
Who cannot join
- Insufficient tissue/blood sample available before treatment as required for the study;
- Patient refusal to undergo dynamic ctDNA testing;
- The primary esophageal lesion is in close proximity to the tracheobronchial tree or major blood vessels, with an investigator-assessed high risk of perforation or major hemorrhage;
- History of malignancies other than esophageal carcinoma within the past 5 years (except for curatively treated localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or localized prostate cancer);
- History of gastrointestinal bleeding within the past 6 months, or coagulopathy at enrollment, or current thrombolytic or anticoagulant therapy indicating a high risk of bleeding;
- Severe cardiovascular or cerebrovascular diseases;
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- History of interstitial lung disease or active pneumonia/tuberculosis;
- Severe allergic reactions to paclitaxel/cisplatin or any monoclonal antibody;
- Any other condition deemed inappropriate for participation in this study as judged by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000
- Recruiting
The central Hospital of Lishui City
Lishui, Zhejiang, 323000
About this study
Esophageal squamous cell carcinoma (ESCC) continues to exhibit high incidence and mortality rates in China, with the majority of patients diagnosed at middle to advanced stages. Concurrent chemoradiotherapy (CCRT) is the standard treatment for unresectable locally advanced ESCC. The 5-year survival rate for advanced esophageal cancer remains below 20%. Immunotherapy has demonstrated definitive efficacy and a favorable toxicity profile in advanced ESCC, and preliminary results of its combination with radiotherapy have been reported. Induction immunochemotherapy followed by concurrent chemoradiotherapy represents a feasible combined treatment strategy. However, optimal biomarkers to identify patients who would benefit from this approach are still lacking. Circulating tumor DNA (ctDNA) status can accurately guide treatment implementation and predict tumor progression. Studies have shown that ctDNA changes precede imaging evidence of recurrence or metastasis, and ctDNA detection can sensitively predict tumor progression and prognosis. Therefore, it is necessary to dynamically monitor ctDNA changes throughout the course of induction immunochemotherapy followed by radical concurrent chemoradiotherapy in esophageal cancer and explore its correlation with prognosis.
- Conditions
- Esophageal Cancer, ctDNA
- Being tested
- Induction Immunochemotherapy
- Keywords
- esophageal cancer, ctDNA, chemoradiotherapy, induction immunochemotherapy, prognosis
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction ImmunochemotherapyDiagnostic test
Induction Immunochemotherapy:Toripalimab 240 mg (immunotherapy) combined with paclitaxel (135 mg/m²) and cisplatin (75 mg/m²) chemotherapy, administered every 3 weeks for 2 cycles. Other Names: - Radiotherapy: 95% PTV 50-50.4 Gy/25-28 fractions, 1.8-2 Gy/fraction; 5 days per week. - Chemotherapy: Weekly paclitaxel (50 mg/m²) combined with cisplatin (25 mg/m²) for 5 cycles. ctDNA Analysis:Initial tissue and blood ctDNA testing prior to treatment (T0) is based on next-generation sequencing (NGS) technology, utilizing tumor-informed assays. Blood ctDNA samples will be collected before chemoradiotherapy, after 20 fractions of radiotherapy, and every 3 months following completion of chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Induction immunochemotherapy followed by radical concurrent chemoradiotherapy | Experimental | This is a single-arm, non-randomized study Diagnostic Tests: ctDNA Analysis Dynamic monitoring of ctDNA changes in patients with esophageal cancer. Receives: Diagnostic Test: Induction Immunochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
We aim to evaluate the progression-free survival (PFS) of patients with unresectable esophageal squamous cell carcinoma who accept concurrent chemoradiotherapy and received sequential treatment with Triptolide injection after radiotherapy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start10 Dec 2024
- Primary completion31 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Central Hospital of Lishui City
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Jiaxing University, People's Hospital of Quzhou, Jinhua Central Hospital
- Responsible party
- Principal investigator, Zhifeng Tian,MD, The Central Hospital of Lishui City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792786
- Sponsor's protocol ID
- ZJLSRT002
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of the study were inconclusive.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring
- ClinicalTrials.gov ID
- NCT06792786
- Acronym / sponsor ID
- ZJLSRT002
- Conditions
- Esophageal Cancer, ctDNA
- Keywords
- esophageal cancer, ctDNA, chemoradiotherapy, induction immunochemotherapy, prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Central Hospital of Lishui CityUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Jiaxing University, People's Hospital of Quzhou, Jinhua Central Hospital
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Jan 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.
Esophageal squamous cell carcinoma (ESCC) continues to exhibit high incidence and mortality rates in China, with the majority of patients diagnosed at middle to advanced stages. Concurrent chemoradiotherapy (CCRT) is the standard treatment for unresectable locally advanced ESCC. The 5-year survival rate for advanced esophageal cancer remains below 20%. Immunotherapy has demonstrated definitive efficacy and a favorable toxicity profile in advanced ESCC, and preliminary results of its combination with radiotherapy have been reported. Induction immunochemotherapy followed by concurrent chemoradiotherapy represents a feasible combined treatment strategy. However, optimal biomarkers to identify patients who would benefit from this approach are still lacking. Circulating tumor DNA (ctDNA) status can accurately guide treatment implementation and predict tumor progression. Studies have shown that ctDNA changes precede imaging evidence of recurrence or metastasis, and ctDNA detection can sensitively predict tumor progression and prognosis. Therefore, it is necessary to dynamically monitor ctDNA changes throughout the course of induction immunochemotherapy followed by radical concurrent chemoradiotherapy in esophageal cancer and explore its correlation with prognosis.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction immunochemotherapy followed by radical concurrent chemoradiotherapy | Experimental | Diagnostic Test: Induction ImmunochemotherapyThis is a single-arm, non-randomized study Diagnostic Tests: ctDNA Analysis Dynamic monitoring of ctDNA changes in patients with esophageal cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All subjects must sign an informed consent form before initiating any study-related procedures;
- All patients must be aged ≥18 years and ≤75 years;
- Histologically or cytologically confirmed esophageal cancer (squamous cell carcinoma);
- Clinical stage II-IVa, assessed by a surgeon as inoperable, or patient refusal of surgery;
- No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer;
Key exclusion criteria (9 listed)
- Insufficient tissue/blood sample available before treatment as required for the study;
- Patient refusal to undergo dynamic ctDNA testing;
- The primary esophageal lesion is in close proximity to the tracheobronchial tree or major blood vessels, with an investigator-assessed high risk of perforation or major hemorrhage;
- History of malignancies other than esophageal carcinoma within the past 5 years (except for curatively treated localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or localized prostate cancer);
- History of gastrointestinal bleeding within the past 6 months, or coagulopathy at enrollment, or current thrombolytic or anticoagulant therapy indicating a high risk of bleeding;
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 |
|---|---|---|
| Induction ImmunochemotherapyInduction Immunochemotherapy:Toripalimab 240 mg (immunotherapy) combined with paclitaxel (135 mg/m²) and cisplatin (75 mg/m²) chemotherapy, administered every 3 weeks for 2 cycles. Other Names: - Radiotherapy: 95% PTV 50-50.4 Gy/25-28 fractions, 1.8-2 Gy/fraction; 5 days per week. - Chemotherapy: Weekly paclitaxel (50 mg/m²) combined with cisplatin (25 mg/m²) for 5 cycles. ctDNA Analysis:Initial tissue and blood ctDNA testing prior to treatment (T0) is based on next-generation sequencing (NGS) technology, utilizing tumor-informed assays. Blood ctDNA samples will be collected before chemoradiotherapy, after 20 fractions of radiotherapy, and every 3 months following completion of chemoradiotherapy. | Diagnostic test | Induction immunochemotherapy followed by radical concurrent chemoradiotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: one year
We aim to evaluate the progression-free survival (PFS) of patients with unresectable esophageal squamous cell carcinoma who accept concurrent chemoradiotherapy and received sequential treatment with Triptolide injection after radiotherapy.
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 23 Mar 2026.
- Individual participant dataSharing planned: Undecided. The results of the study were inconclusive.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction Immunochemotherapy in people with Esophageal Cancer and ctDNA, run by The Central Hospital of Lishui City at 2 sites 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 12 inclusion and 9 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Zhifeng Tian, MD (+8613515789419, tzf419@hotmail.com), 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: one 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 23 Mar 2026; AzTrials last refreshed its copy on 28 Oct 2026.