Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT07559045
Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy) and Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy) in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Second Affiliated Hospital of Zunyi Medical University at 1 site in China.
Trial summary
This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy) and Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Jun 2028
- 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
- Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization
- Measurable or evaluable disease per RECIST 1.1
- Willing to provide written informed consent
Who cannot join
- Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC
- History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
- Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)
- Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody)
- Pregnant or lactating women
- Participation in another clinical trial within 30 days prior to randomization
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, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
Zunyi, Guizhou, 563000
lei zhou, Master, +86-851-18212154044, jsdxzl@126.com
About this study
Official title: Efficacy and Safety of Induction Chemo-Immunotherapy Followed by Radiotherapy vs Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized, Two-Arm, Phase II Study
This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.
Read the detailed description
This is a prospective, randomized, two-arm, phase II clinical trial investigating induction chemo-immunotherapy followed by sequential radiotherapy versus concurrent chemo-immunotherapy plus radiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC).
Current standard of care for unresectable locally advanced ESCC is definitive concurrent chemoradiotherapy. However, outcomes remain suboptimal, with high rates of local recurrence and distant metastasis. The addition of PD-1 inhibitors to concurrent chemoradiotherapy has shown promising activity in recent studies, but optimal sequencing and integration of immunotherapy with radiotherapy are still under investigation.
This trial is designed to evaluate whether an induction strategy with chemo-immunotherapy followed by radiotherapy can improve response rates and long-term survival compared to the standard concurrent approach. Patients will be randomized to receive either:
- Experimental arm: Three cycles of induction chemo-immunotherapy, followed by definitive thoracic radiotherapy, then maintenance immunotherapy for up to one year.
- Control arm: Concurrent chemo-immunotherapy plus definitive thoracic radiotherapy, followed by maintenance immunotherapy for up to one year.
The primary objective is to compare the efficacy of the two regimens in terms of complete response and progression-free survival. Safety, tolerability, and quality of life will also be assessed to support the risk-benefit profile of each strategy.
- Being tested
- Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy), Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)
- Keywords
- Esophageal Squamous Cell Carcinoma, Chemo-Immunotherapy, Induction Therapy, Concurrent Chemoradiotherapy, PD-1 Inhibitor
- 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 plus Cisplatin or Carboplatin (Induction Chemotherapy)Drug
Paclitaxel 150-175 mg/m² combined with cisplatin 75 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously every 3 weeks for 3 cycles, concurrent with PD-1 antibody induction therapy for unresectable stage III-IVA esophageal squamous cell carcinoma.
Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)Drug
Paclitaxel 50 mg/m² combined with cisplatin 25 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously once weekly for 5 cycles, concurrent with thoracic radiotherapy (50.4Gy in 28 fractions) for unresectable stage III-IVA esophageal squamous cell carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Chemo-Immunotherapy Induction + Radiotherapy + PD-1 Maintenance | Experimental | Patients receive 3 cycles of PD-1 antibody plus chemotherapy induction therapy, followed by thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year). Receives: Drug: Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy) |
| Control Group: Concurrent Chemoradiotherapy + PD-1 Maintenance | Active comparator | Patients receive weekly paclitaxel + cisplatin/carboplatin concurrent with thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year). Receives: Drug: Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
Proportion of patients achieving complete response (CR) per RECIST 1.1, assessed by investigators at 3 months after completion of radiotherapy
Measured: 3 months after completion of radiotherapy
1-Year Progression-Free Survival (PFS) Rate
Proportion of patients alive and without disease progression at 1 year after randomization
Measured: 1 year after randomization
Secondary outcomes (9)
Overall Survival (OS)
Time from randomization to death from any cause
Measured: Up to 3 years after randomization
Progression-Free Survival (PFS)
Time from randomization to first documented disease progression or death from any cause, whichever occurs first
Measured: Up to 3 years after randomization
Duration of Response (DOR)
Time from first documentation of objective response (CR/PR) to first documented disease progression or death
Measured: Up to 3 years after randomization
Objective Response Rate (ORR)
Proportion of patients achieving CR or partial response (PR) per RECIST 1.1
Measured: Up to 3 years after randomization
Local Regional Failure-Free Survival (LRFS)
Time from randomization to first local or regional recurrence or death
Measured: Up to 3 years after randomization
Distant Metastasis-Free Survival (DMFS)
Time from randomization to first distant metastasis or death
Measured: Up to 3 years after randomization
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence and severity of TEAEs (graded per CTCAE 5.0) during treatment and follow-up
Measured: From first study treatment to 30 days after last treatment
EORTC QLQ-OES18 Symptom Score Change
Change in esophageal cancer-specific symptom score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal 18 (EORTC QLQ-OES18) from baseline to post-treatment follow-ups. The scale ranges from 0 to 100, with higher scores indicating more severe symptoms and worse quality of life.
Measured: Baseline, 3 months, 6 months, 12 months after radiotherapy
EORTC QLQ-C30 Quality of Life Score Change
Change in quality of life score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to post-treatment follow-ups. The scale ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline, 3 months, 6 months, 12 months after radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Jun 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.
- 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
- Model description
- This is a randomized, double-blind, parallel-group phase II trial comparing chemo-immunotherapy induction followed by radiotherapy versus concurrent chemoradiotherapy in patients with unresectable stage III-IVA esophageal squamous cell carcinoma.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Zunyi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Zhou, Master, Principal investigator, The Second Affiliated Hospital of Zunyi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559045
- Sponsor's protocol ID
- KYLL-2025-143
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Induction Chemo-Immunotherapy Followed by Radiotherapy vs Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized, Two-Arm, Phase II Study
- ClinicalTrials.gov ID
- NCT07559045
- Acronym / sponsor ID
- KYLL-2025-143
- Keywords
- Esophageal Squamous Cell Carcinoma, Chemo-Immunotherapy, Induction Therapy, Concurrent Chemoradiotherapy, PD-1 Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Zunyi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Apr 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, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.
Detailed description
This is a prospective, randomized, two-arm, phase II clinical trial investigating induction chemo-immunotherapy followed by sequential radiotherapy versus concurrent chemo-immunotherapy plus radiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC).
Current standard of care for unresectable locally advanced ESCC is definitive concurrent chemoradiotherapy. However, outcomes remain suboptimal, with high rates of local recurrence and distant metastasis. The addition of PD-1 inhibitors to concurrent chemoradiotherapy has shown promising activity in recent studies, but optimal sequencing and integration of immunotherapy with radiotherapy are still under investigation.
This trial is designed to evaluate whether an induction strategy with chemo-immunotherapy followed by radiotherapy can improve response rates and long-term survival compared to the standard concurrent approach. Patients will be randomized to receive either:
- Experimental arm: Three cycles of induction chemo-immunotherapy, followed by definitive thoracic radiotherapy, then maintenance immunotherapy for up to one year.
- Control arm: Concurrent chemo-immunotherapy plus definitive thoracic radiotherapy, followed by maintenance immunotherapy for up to one year.
The primary objective is to compare the efficacy of the two regimens in terms of complete response and progression-free survival. Safety, tolerability, and quality of life will also be assessed to support the risk-benefit profile of each strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, parallel-group phase II trial comparing chemo-immunotherapy induction followed by radiotherapy versus concurrent chemoradiotherapy in patients with unresectable stage III-IVA esophageal squamous cell carcinoma.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Chemo-Immunotherapy Induction + Radiotherapy + PD-1 Maintenance | Experimental | Drug: Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy)Patients receive 3 cycles of PD-1 antibody plus chemotherapy induction therapy, followed by thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year). |
| Control Group: Concurrent Chemoradiotherapy + PD-1 Maintenance | Active comparator | Drug: Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)Patients receive weekly paclitaxel + cisplatin/carboplatin concurrent with thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization
- Measurable or evaluable disease per RECIST 1.1
- Willing to provide written informed consent
Key exclusion criteria (6 listed)
- Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC
- History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
- Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)
- Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody)
- Pregnant or lactating women
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 plus Cisplatin or Carboplatin (Induction Chemotherapy)Paclitaxel 150-175 mg/m² combined with cisplatin 75 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously every 3 weeks for 3 cycles, concurrent with PD-1 antibody induction therapy for unresectable stage III-IVA esophageal squamous cell carcinoma. | Drug | Experimental Group: Chemo-Immunotherapy Induction + Radiotherapy + PD-1 Maintenance |
| Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)Paclitaxel 50 mg/m² combined with cisplatin 25 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously once weekly for 5 cycles, concurrent with thoracic radiotherapy (50.4Gy in 28 fractions) for unresectable stage III-IVA esophageal squamous cell carcinoma. | Drug | Control Group: Concurrent Chemoradiotherapy + PD-1 Maintenance |
Primary outcome
Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
Time frame: 3 months after completion of radiotherapy
Proportion of patients achieving complete response (CR) per RECIST 1.1, assessed by investigators at 3 months after completion of radiotherapy
1-Year Progression-Free Survival (PFS) Rate
Time frame: 1 year after randomization
Proportion of patients alive and without disease progression at 1 year after randomization
9 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 years after randomization
Progression-Free Survival (PFS)
Time frame: Up to 3 years after randomization
Duration of Response (DOR)
Time frame: Up to 3 years after randomization
Objective Response Rate (ORR)
Time frame: Up to 3 years after randomization
Local Regional Failure-Free Survival (LRFS)
Time frame: Up to 3 years after randomization
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to 3 years after randomization
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first study treatment to 30 days after last treatment
EORTC QLQ-OES18 Symptom Score Change
Time frame: Baseline, 3 months, 6 months, 12 months after radiotherapy
EORTC QLQ-C30 Quality of Life Score Change
Time frame: Baseline, 3 months, 6 months, 12 months 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 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Lei Zhou, Master principal investigator
The Second Affiliated Hospital of Zunyi Medical University
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 plus Cisplatin or Carboplatin (Induction Chemotherapy) and Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy) in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Second Affiliated Hospital of Zunyi Medical 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 5 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: looking for participants now, as of the sponsor's last update on 30 Apr 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 Jian-Guo Zhou, PhD (+86-851-18212154044, jsdxzl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed) (time frame: 3 months after completion of radiotherapy). The study lists 2 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 30 Apr 2026.