ESCCPhase 2NCT07015489
Concurrent Radiotherapy Following Induction Chemoimmunotherapy for Locally Advanced Esophageal Cancer
A Phase 2 study testing induction chemotherapy and immunotherapy in people with ESCC, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Esophageal cancer is one of the most common malignancies, and concurrent chemoradiotherapy (CRT) is the standard treatment for unresectable, locally advanced esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESCC
- What is being tested?
- induction chemotherapy and immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 May 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily agrees to participate in this study, has signed the informed consent form, demonstrates good compliance, and agrees to cooperate with follow-up.
- Age ≥ 18 years, regardless of gender.
- Histologically confirmed locally advanced esophageal squamous cell carcinoma, clinical stage II-IV and deemed unresectable (including unresectable cases, patients with surgical contraindications, or those who refuse surgery) based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system. Pre-treatment clinical staging: cT1N2-3M0, cT2-4bN0-3M0, or M1 limited to non-regional lymph node metastasis (excluding distant organ metastasis).
- At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
- No prior systemic antitumor therapy (including but not limited to systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy,local treatments, or other investigational treatments).
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
Show all 10Show fewer
- Expected survival of ≥ 6 months.
- Adequate function of major organs as defined below (use of any blood components or growth factors is not allowed within 2 weeks prior to screening):
- absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 100 g/L (female), ≥ 110 g/L (male); Serum albumin ≥ 2.8 g/dL; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase (ALP) ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (patients receiving stable doses of anticoagulants such as low molecular weight heparin or warfarin with INR within the expected therapeutic range of the anticoagulant may be eligible for screening).
- Female participants: All women of childbearing potential must have a negative serum pregnancy test during screening and must agree to use reliable contraception from the time of signing the informed consent form until 3 months after the last dose.
Who cannot join
- History of esophageal cancer surgery.
- History of fistula caused by primary tumor invasion.
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
- Poor nutritional status, with ≥10% body weight loss within 2 months prior to screening and no significant improvement after nutritional intervention.
- Major surgery or severe trauma within 4 weeks prior to first administration of the investigational drug.
- Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
Show all 13Show fewer
- Prior or ongoing treatment with any of the following:
- Anti-programmed death-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) antibody therapy, chemotherapy, radiotherapy, or targeted therapy.
- Use of any investigational drug within 4 weeks prior to first administration of the study drug.
- Systemic use of corticosteroids (daily dose >10 mg prednisone or equivalent) or other immunosuppressive agents within 2 weeks prior to first dose of the study drug, except for local esophageal inflammation, prophylaxis against allergies, or antiemetic use. Special circumstances require consultation with the sponsor. Inhaled or topical steroids and adrenal hormone replacement at >10 mg/day prednisone-equivalent are allowed in the absence of active autoimmune disease.
- Receipt of anti-tumor vaccines or live vaccines within 4 weeks prior to first dose of the study drug.
- Presence or history of any active autoimmune disease (e.g., interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, or hypothyroidism); exceptions include vitiligo, childhood asthma/allergies now resolved without intervention, autoimmune hypothyroidism on stable thyroid hormone replacement, and type I diabetes mellitus on stable insulin regimen.
- History of immunodeficiency, including human immunodeficiency virus (HIV) positive status or other acquired or congenital immunodeficiency diseases, or history of organ or allogeneic bone marrow transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: A Prospective, Single-center Phase II Clinical Study of Concurrent Radiotherapy Following Induction Chemoimmunotherapy for Locally Advanced Esophageal Cancer
Esophageal cancer is one of the most common malignancies, and concurrent chemoradiotherapy (CRT) is the standard treatment for unresectable, locally advanced esophageal squamous cell carcinoma. In recent years, studies have suggested that combining immunotherapy with definitive CRT may further improve treatment outcomes. Currently, several clinical trials are underway to evaluate the efficacy of immunotherapy combined with chemotherapy (chemo) and radiotherapy in patients with unresectable, locally advanced esophageal cancer. The investigators plan to conduct a single-arm, prospective, single-center phase II clinical study to investigate the efficacy and safety of induction chemo and immunotherapy followed by concurrent radiotherapy (RT) in the treatment of locally advanced esophageal cancer. A total of 44 patients will be enrolled.
- Conditions
- ESCC
- Being tested
- induction chemotherapy and immunotherapy
- Keywords
- induction immunochemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction chemotherapy and immunotherapyDrug
All patients will first receive 2 cycles of induction chemoimmunotherapy, followed by radiotherapy. During radiotherapy, 2 concurrent cycles of chemoimmunotherapy will be administered. Afterward, maintenance immunotherapy will continue for up to one year.
Chemotherapy regimen: Paclitaxel: 135 mg/m², Day 1, every 3 weeks (Q3W); Carboplatin: area under the curve (AUC) = 5, intravenous infusion over more than 30 minutes, Day 2, Q3W; Alternatively, Nedaplatin: 75 mg/m², Day 2, Q3W.
Immunotherapy regimen: programmed death-1 (PD-1) inhibitor (e.g., Camrelizumab): Day 0, intravenous infusion, Q3W; Continued until disease progression (PD) or unacceptable toxicity, for a maximum duration of one year.
Radiotherapy: Prescribed dose: 95% of the planning target volume (PTV) and planning target volume for nodal disease (PTV-nd) should receive 50-50.4 Gy over 25-28 fractions; Fraction dose range: 1.8-2.0 Gy per fraction, 5 days per week; External beam radiotherapy to the chest.
| Study group | Role | What they receive |
|---|---|---|
| Induction therapy group | Experimental | Not described Receives: Drug: induction chemotherapy and immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
The time from the start of treatment to tumor progression (of any form) or death from any cause.
Measured: From treatment initiation through study completion (up to 3 years)
Secondary outcomes (2)
OS (overall survival)
Measured: From treatment initiation through study completion (up to 3 years)
Adverse Event (AE)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jan 2022
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015489
- Sponsor's protocol ID
- GXL-006
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 11 Jun 2025
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center Phase II Clinical Study of Concurrent Radiotherapy Following Induction Chemoimmunotherapy for Locally Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT07015489
- Acronym / sponsor ID
- GXL-006
- Conditions
- ESCC
- Keywords
- induction immunochemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 11 Jun 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 cancer is one of the most common malignancies, and concurrent chemoradiotherapy (CRT) is the standard treatment for unresectable, locally advanced esophageal squamous cell carcinoma. In recent years, studies have suggested that combining immunotherapy with definitive CRT may further improve treatment outcomes. Currently, several clinical trials are underway to evaluate the efficacy of immunotherapy combined with chemotherapy (chemo) and radiotherapy in patients with unresectable, locally advanced esophageal cancer. The investigators plan to conduct a single-arm, prospective, single-center phase II clinical study to investigate the efficacy and safety of induction chemo and immunotherapy followed by concurrent radiotherapy (RT) in the treatment of locally advanced esophageal cancer. A total of 44 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction therapy group | Experimental | Drug: induction chemotherapy and immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient voluntarily agrees to participate in this study, has signed the informed consent form, demonstrates good compliance, and agrees to cooperate with follow-up.
- Age ≥ 18 years, regardless of gender.
- Histologically confirmed locally advanced esophageal squamous cell carcinoma, clinical stage II-IV and deemed unresectable (including unresectable cases, patients with surgical contraindications, or those who refuse surgery) based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system. Pre-treatment clinical staging: cT1N2-3M0, cT2-4bN0-3M0, or M1 limited to non-regional lymph node metastasis (excluding distant organ metastasis).
- At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
- No prior systemic antitumor therapy (including but not limited to systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy,local treatments, or other investigational treatments).
Key exclusion criteria (13 listed)
- History of esophageal cancer surgery.
- History of fistula caused by primary tumor invasion.
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
- Poor nutritional status, with ≥10% body weight loss within 2 months prior to screening and no significant improvement after nutritional intervention.
- Major surgery or severe trauma within 4 weeks prior to first administration of the investigational drug.
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 chemotherapy and immunotherapyAll patients will first receive 2 cycles of induction chemoimmunotherapy, followed by radiotherapy. During radiotherapy, 2 concurrent cycles of chemoimmunotherapy will be administered. Afterward, maintenance immunotherapy will continue for up to one year. Chemotherapy regimen: Paclitaxel: 135 mg/m², Day 1, every 3 weeks (Q3W); Carboplatin: area under the curve (AUC) = 5, intravenous infusion over more than 30 minutes, Day 2, Q3W; Alternatively, Nedaplatin: 75 mg/m², Day 2, Q3W. Immunotherapy regimen: programmed death-1 (PD-1) inhibitor (e.g., Camrelizumab): Day 0, intravenous infusion, Q3W; Continued until disease progression (PD) or unacceptable toxicity, for a maximum duration of one year. Radiotherapy: Prescribed dose: 95% of the planning target volume (PTV) and planning target volume for nodal disease (PTV-nd) should receive 50-50.4 Gy over 25-28 fractions; Fraction dose range: 1.8-2.0 Gy per fraction, 5 days per week; External beam radiotherapy to the chest. | Drug | Induction therapy group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From treatment initiation through study completion (up to 3 years)
The time from the start of treatment to tumor progression (of any form) or death from any cause.
2 secondary outcomes
OS (overall survival)
Time frame: From treatment initiation through study completion (up to 3 years)
Adverse Event (AE)
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for ESCC
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
Active, not recruiting
Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection
Esophageal Squamous Cell Carcinoma (ESCC), High-Grade Intraepithelial Neoplasia
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer)
RecruitingPhase 2
QL1706 Plus Celecoxib in Advanced Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
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.
The record lists no contact. Use the official record to reach the sponsor.
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 induction chemotherapy and immunotherapy in people with ESCC, run by The First Affiliated Hospital with Nanjing 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 10 inclusion and 13 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: finished, as of the sponsor's last update on 11 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From treatment initiation through study completion (up to 3 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 11 Jun 2025.