Esophageal Squamous Cell Carcinoma (ESCC)Phase 2Keystone006NCT07721103
Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin) and Sequential Chemoradiotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Esophageal squamous cell carcinoma (ESCC) is a common and aggressive malignancy with poor prognosis, particularly in patients with locally advanced disease. Neoadjuvant chemoimmunotherapy has shown promising antitumor activity and may improve pathological response; however, a proportion of patients achieve only stable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin) and Sequential Chemoradiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2026to 31 Dec 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Participants must meet all of the following criteria:
- Provide written informed consent before enrollment.
- Age >18 years, male or female.
- Histologically confirmed thoracic esophageal squamous cell carcinoma (ESCC).
- Locally advanced, resectable disease according to AJCC/UICC 8th edition TNM staging system, defined as:
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- cT3-4aN0-2M0 or cT1-2N1-2M0;
- No evidence of distant metastasis;
- Considered initially resectable by a multidisciplinary surgical team.
- Patients who have received neoadjuvant chemoimmunotherapy and have measurable disease response assessment according to RECIST v1.1, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
- At least one measurable lesion according to RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival time >6 months.
- Adequate organ function meeting the following criteria:
- Bone marrow function:
- Absolute neutrophil count ≥1,500/mm³;
- Platelet count ≥100,000/mm³;
- Hemoglobin ≥9 g/dL.
- Renal function:
- Serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min.
- Hepatic function:
- Total bilirubin ≤1.5 × upper limit of normal (ULN);
- AST and ALT ≤1.5 × ULN.
- Participants of childbearing potential must agree to use medically approved contraception during study treatment and for 3 months after completion of treatment. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and must not be breastfeeding.
- Willingness and ability to comply with study procedures, safety assessments, and survival follow-up.
Who cannot join
- -
- Participants will be excluded if any of the following criteria apply:
- Evidence of distant metastasis.
- Previous or concurrent malignancy, except adequately treated basal cell carcinoma of skin or cervical carcinoma in situ.
- Previous thoracic radiotherapy.
- Previous treatment with PD-1, PD-L1, or CTLA-4 inhibitors, or known hypersensitivity to PD-1 inhibitors or macromolecular protein products.
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- Active autoimmune disease or history of clinically significant autoimmune disease requiring systemic treatment.
- Current use of immunosuppressive therapy or systemic corticosteroids exceeding the equivalent of prednisone 10 mg/day within 2 weeks before enrollment.
- Clinically significant ascites or pleural effusion requiring therapeutic drainage.
- Uncontrolled cardiovascular disease, including:
- NYHA class II or higher heart failure;
- Unstable angina;
- Myocardial infarction within 1 year;
- Clinically significant arrhythmias requiring treatment.
- Significant coagulation abnormalities, bleeding tendency, or ongoing thrombolytic/anticoagulant therapy.
- Active gastrointestinal disorders associated with bleeding or perforation risk, including esophageal varices, active gastric/duodenal ulcer, ulcerative colitis, portal hypertension, or active tumor bleeding.
- History of severe bleeding, clinically significant hemoptysis, or thromboembolic events within specified periods.
- Active infection or unexplained fever >38.5°C before treatment initiation.
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.
- History or evidence of interstitial lung disease, pulmonary fibrosis, radiation pneumonitis, drug-induced pneumonitis, pneumoconiosis, or severe pulmonary impairment.
- Known immunodeficiency, including HIV infection, or active hepatitis infection requiring exclusion according to protocol criteria.
- Participation in another clinical trial within 1 month before enrollment or concurrent systemic anticancer therapy.
- Receipt of live vaccines within 4 weeks before treatment or planned live vaccination during study treatment.
- Known history of substance abuse, alcoholism, or drug abuse.
- Inability or unwillingness to comply with study-related procedures, examinations, or required costs.
- Any other medical, psychological, social, or safety-related condition judged by the investigator to make the participant unsuitable for study participation.
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
Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
Hongjing Jiang, 18622221069, jianghongjing@tmu.edu.cn
About this study
Official title: Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
Esophageal squamous cell carcinoma (ESCC) is a common and aggressive malignancy with poor prognosis, particularly in patients with locally advanced disease. Neoadjuvant chemoimmunotherapy has shown promising antitumor activity and may improve pathological response; however, a proportion of patients achieve only stable disease (SD) or progressive disease (PD) after initial treatment and may have limited benefit from proceeding directly to surgery.
This prospective, single-center, phase II clinical study aims to evaluate an early response-guided sequential selective radiotherapy strategy after neoadjuvant chemoimmunotherapy in patients with locally advanced, resectable ESCC. Patients will initially receive neoadjuvant chemotherapy combined with PD-1 inhibitor therapy. Based on radiological response assessment, patients with major response (complete response or partial response) will proceed directly to radical surgery, whereas patients with insufficient response (stable disease or progressive disease but still considered resectable) will receive sequential chemoradiotherapy followed by surgery.
The study aims to assess the safety and efficacy of this individualized treatment strategy, with primary evaluation focusing on pathological response, surgical outcomes, and treatment-related adverse events. Exploratory analyses will investigate potential biomarkers associated with treatment response and prognosis.
Read the detailed description
Esophageal squamous cell carcinoma (ESCC) is a major subtype of esophageal cancer and remains associated with poor outcomes, particularly in patients with locally advanced disease. Neoadjuvant chemoimmunotherapy has recently emerged as a promising treatment approach for resectable ESCC, improving tumor response and pathological remission. However, a subset of patients demonstrates limited response after initial therapy, and optimal management strategies for these patients remain uncertain.
Radiotherapy may enhance antitumor immune responses through modulation of the tumor microenvironment and may provide additional tumor control in patients with insufficient response to initial systemic therapy. Therefore, an individualized treatment strategy guided by early treatment response may help optimize therapeutic benefit while preserving opportunities for curative surgery.
This study evaluates an early response-guided sequential selective radiotherapy strategy for patients with locally advanced resectable ESCC after neoadjuvant chemoimmunotherapy. Treatment decisions will be adapted according to early tumor response assessment and multidisciplinary evaluation, aiming to provide additional local treatment for patients with inadequate response while avoiding unnecessary radiotherapy in patients with favorable response.
The study will assess the safety, feasibility, and clinical outcomes of this response-guided approach. In addition, exploratory analyses will investigate potential biomarkers associated with treatment response and prognosis, including changes in the tumor immune microenvironment and peripheral blood biomarkers.
This study aims to develop a personalized treatment strategy for locally advanced ESCC based on early therapeutic response and to improve clinical outcomes through optimized treatment selection.
- Being tested
- Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin), Sequential Chemoradiotherapy
- Keywords
- Locally advanced esophageal cancer, Neoadjuvant therapy, Adaptive treatment strategy, Response-guided therapy
- 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.
Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin)Drug
Participants will receive neoadjuvant chemoimmunotherapy before surgery.
The regimen includes:
Tislelizumab (PD-1 inhibitor): 200 mg administered intravenously once every 3 weeks for 2 cycles.
Paclitaxel: 135 mg/m² administered intravenously on Day 1 of each 3-week cycle for 2 cycles.
Cisplatin: 60 mg/m² administered intravenously on Day 1 of each 3-week cycle for 2 cycles.
After completion of neoadjuvant chemoimmunotherapy, tumor response will be assessed. Treatment decisions will be guided by early response evaluation and multidisciplinary surgical assessment.
Sequential ChemoradiotherapyRadiation
Participants with inadequate response after neoadjuvant chemoimmunotherapy but remaining eligible for curative surgery will receive sequential chemoradiotherapy followed by surgery.
Concurrent chemoradiotherapy consists of:
Radiotherapy: 1.8 Gy per fraction, 5 fractions per week, for 5 weeks, with a total dose of 41.4 Gy in 23 fractions.
Chemotherapy: weekly concurrent chemotherapy with paclitaxel and platinum-based chemotherapy during radiotherapy.
The treatment aims to improve local tumor control before radical surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Response-guided Sequential Treatment | Experimental | Participants will receive neoadjuvant chemoimmunotherapy followed by individualized treatment according to early tumor response assessment. Patients with favorable response will proceed to surgery, while patients with insufficient response but remaining resectable disease will receive sequential chemoradiotherapy followed by surgery. Receives: Drug: Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin); Radiation: Sequential Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Equivalent Major Pathological Response Rate (ITT-MPR)
Measured: Up to approximately 1.5 years
Secondary outcomes (10)
R0 Resection Rate
The proportion of participants achieving microscopically complete tumor resection (R0 resection) after surgery.
Measured: At the time of surgery after completion of neoadjuvant treatment
Surgical Completion Rate
The proportion of participants who successfully complete planned surgical resection after neoadjuvant treatment.
Measured: At the time of surgery after completion of neoadjuvant treatment
Pathological Complete Response (pCR) Rate
The proportion of participants achieving pathological complete response (ypT0N0) based on surgical pathology evaluation after neoadjuvant treatment.
Measured: At the time of 1 month after resection
Tumor Regression Grade (TRG)
Tumor regression grade assessed by pathological examination after surgical resection.
Measured: At the time of surgery after completion of neoadjuvant treatment
Pathological Lymph Node Status (ypN0 Rate)
The proportion of participants without residual metastatic lymph nodes (ypN0) based on postoperative pathological evaluation.
Measured: At the time of surgery after completion of neoadjuvant treatment
Tumor Downstaging Rate
The proportion of participants achieving pathological downstaging compared with baseline clinical staging after neoadjuvant treatment.
Measured: At the time of surgery after completion of neoadjuvant treatment
Objective Response Rate (ORR)
The proportion of participants achieving complete response or partial response according to RECIST 1.1 criteria.
Measured: After completion of neoadjuvant treatment before surgery (approximately 12 weeks after initiation of study treatment)
Disease Control Rate (DCR)
The proportion of participants achieving complete response, partial response, or stable disease according to RECIST 1.1 criteria.
Measured: After completion of neoadjuvant treatment before surgery
Treatment-related Adverse Events
The incidence and severity of treatment-related adverse events assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From initiation of study treatment until 30 days after completion of treatment
Perioperative Complications
The incidence of postoperative complications occurring after surgical resection.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start14 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (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.
- 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721103
- Sponsor's protocol ID
- E20260722
- Acronym
- Keystone006
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared based on the request from other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07721103
- Acronym / sponsor ID
- Keystone006 / E20260722
- Keywords
- Locally advanced esophageal cancer, Neoadjuvant therapy, Adaptive treatment strategy, Response-guided therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 14 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 22 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.
Esophageal squamous cell carcinoma (ESCC) is a common and aggressive malignancy with poor prognosis, particularly in patients with locally advanced disease. Neoadjuvant chemoimmunotherapy has shown promising antitumor activity and may improve pathological response; however, a proportion of patients achieve only stable disease (SD) or progressive disease (PD) after initial treatment and may have limited benefit from proceeding directly to surgery.
This prospective, single-center, phase II clinical study aims to evaluate an early response-guided sequential selective radiotherapy strategy after neoadjuvant chemoimmunotherapy in patients with locally advanced, resectable ESCC. Patients will initially receive neoadjuvant chemotherapy combined with PD-1 inhibitor therapy. Based on radiological response assessment, patients with major response (complete response or partial response) will proceed directly to radical surgery, whereas patients with insufficient response (stable disease or progressive disease but still considered resectable) will receive sequential chemoradiotherapy followed by surgery.
The study aims to assess the safety and efficacy of this individualized treatment strategy, with primary evaluation focusing on pathological response, surgical outcomes, and treatment-related adverse events. Exploratory analyses will investigate potential biomarkers associated with treatment response and prognosis.
Detailed description
Esophageal squamous cell carcinoma (ESCC) is a major subtype of esophageal cancer and remains associated with poor outcomes, particularly in patients with locally advanced disease. Neoadjuvant chemoimmunotherapy has recently emerged as a promising treatment approach for resectable ESCC, improving tumor response and pathological remission. However, a subset of patients demonstrates limited response after initial therapy, and optimal management strategies for these patients remain uncertain.
Radiotherapy may enhance antitumor immune responses through modulation of the tumor microenvironment and may provide additional tumor control in patients with insufficient response to initial systemic therapy. Therefore, an individualized treatment strategy guided by early treatment response may help optimize therapeutic benefit while preserving opportunities for curative surgery.
This study evaluates an early response-guided sequential selective radiotherapy strategy for patients with locally advanced resectable ESCC after neoadjuvant chemoimmunotherapy. Treatment decisions will be adapted according to early tumor response assessment and multidisciplinary evaluation, aiming to provide additional local treatment for patients with inadequate response while avoiding unnecessary radiotherapy in patients with favorable response.
The study will assess the safety, feasibility, and clinical outcomes of this response-guided approach. In addition, exploratory analyses will investigate potential biomarkers associated with treatment response and prognosis, including changes in the tumor immune microenvironment and peripheral blood biomarkers.
This study aims to develop a personalized treatment strategy for locally advanced ESCC based on early therapeutic response and to improve clinical outcomes through optimized treatment selection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Response-guided Sequential Treatment | Experimental | Drug: Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin), Radiation: Sequential ChemoradiotherapyParticipants will receive neoadjuvant chemoimmunotherapy followed by individualized treatment according to early tumor response assessment. Patients with favorable response will proceed to surgery, while patients with insufficient response but remaining resectable disease will receive sequential chemoradiotherapy followed by surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- -
- Provide written informed consent before enrollment.
- Age >18 years, male or female.
- Histologically confirmed thoracic esophageal squamous cell carcinoma (ESCC).
- Locally advanced, resectable disease according to AJCC/UICC 8th edition TNM staging system, defined as:
Key exclusion criteria (26 listed)
- -
- Evidence of distant metastasis.
- Previous or concurrent malignancy, except adequately treated basal cell carcinoma of skin or cervical carcinoma in situ.
- Previous thoracic radiotherapy.
- Previous treatment with PD-1, PD-L1, or CTLA-4 inhibitors, or known hypersensitivity to PD-1 inhibitors or macromolecular protein products.
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 |
|---|---|---|
| Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin)Participants will receive neoadjuvant chemoimmunotherapy before surgery. The regimen includes: Tislelizumab (PD-1 inhibitor): 200 mg administered intravenously once every 3 weeks for 2 cycles. Paclitaxel: 135 mg/m² administered intravenously on Day 1 of each 3-week cycle for 2 cycles. Cisplatin: 60 mg/m² administered intravenously on Day 1 of each 3-week cycle for 2 cycles. After completion of neoadjuvant chemoimmunotherapy, tumor response will be assessed. Treatment decisions will be guided by early response evaluation and multidisciplinary surgical assessment. | Drug | Response-guided Sequential Treatment |
| Sequential ChemoradiotherapyParticipants with inadequate response after neoadjuvant chemoimmunotherapy but remaining eligible for curative surgery will receive sequential chemoradiotherapy followed by surgery. Concurrent chemoradiotherapy consists of: Radiotherapy: 1.8 Gy per fraction, 5 fractions per week, for 5 weeks, with a total dose of 41.4 Gy in 23 fractions. Chemotherapy: weekly concurrent chemotherapy with paclitaxel and platinum-based chemotherapy during radiotherapy. The treatment aims to improve local tumor control before radical surgical resection. | Radiation | Response-guided Sequential Treatment |
Primary outcome
Safety and Tolerability Equivalent Major Pathological Response Rate (ITT-MPR)
Time frame: Up to approximately 1.5 years
10 secondary outcomes
R0 Resection Rate
Time frame: At the time of surgery after completion of neoadjuvant treatment
Surgical Completion Rate
Time frame: At the time of surgery after completion of neoadjuvant treatment
Pathological Complete Response (pCR) Rate
Time frame: At the time of 1 month after resection
Tumor Regression Grade (TRG)
Time frame: At the time of surgery after completion of neoadjuvant treatment
Pathological Lymph Node Status (ypN0 Rate)
Time frame: At the time of surgery after completion of neoadjuvant treatment
Tumor Downstaging Rate
Time frame: At the time of surgery after completion of neoadjuvant treatment
Objective Response Rate (ORR)
Time frame: After completion of neoadjuvant treatment before surgery (approximately 12 weeks after initiation of study treatment)
Disease Control Rate (DCR)
Time frame: After completion of neoadjuvant treatment before surgery
Treatment-related Adverse Events
Time frame: From initiation of study treatment until 30 days after completion of treatment
Perioperative Complications
Time frame: Within 30 days after surgery
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 22 Jul 2026.
- Individual participant dataSharing planned: No. IPD will be shared based on the request from other researchers.
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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 Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin) and Sequential Chemoradiotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Tianjin Medical University Cancer Institute and 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 25 inclusion and 26 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 22 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 Hongjing Jiang, PhD,MD (18622221069, jianghongjing@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability Equivalent Major Pathological Response Rate (ITT-MPR) (time frame: Up to approximately 1.5 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 22 Jul 2026.