Locally Advanced Unresectable Esophageal Squamous Cell CarcinomaPhase 2STELLAR01NCT07530094
Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Camrelizumab in people with Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, run by Ning Jiang, M.D./Ph.D. at 1 site in China.
Trial summary
This study aims to compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in the treatment of locally advanced unresectable esophageal squamous cell… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
- What is being tested?
- Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2027
- 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
- The patient or their legal representative is able to sign the written informed consent form and understands and agrees to comply with the study requirements;
- Age ≥ 18 years and < 75 years at the time of signing the informed consent form, regardless of gender;
- Histologically confirmed esophageal squamous cell carcinoma, confirmed by imaging examinations such as CT, MRI, or PET-CT as locally advanced unresectable ESCC (medically unsuitable for surgery or refusal of surgical intervention), and suitable for cCRT, including: stages II-IVa and certain cases of stage IVb (involving only supraclavicular lymph node metastasis) (AJCC version 8 ) meeting the criteria;
- Estimated life expectancy of at least 6 months;
- ECOG performance status score of 0-2;
- Presence of measurable and/or non-measurable lesions as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
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- No prior systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, biological therapy, local therapy, or other investigational treatments);
- Adequate organ function, as indicated by laboratory test results obtained within 14 days prior to enrollment:
- a. Achieved without the need for blood transfusion, growth factor therapy, or other supportive medications that significantly affect neutrophil count, platelet count, or hemoglobin within ≤ 14 days before sample collection during screening: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 90 g/L;
- b. Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m² using the Chronic Kidney Disease Epidemiology Collaboration equation (Appendix 9);
- c. Serum total bilirubin ≤ 1.5 × ULN (for patients with Gilbert's syndrome, total bilirubin must be ≤ 3 × ULN);
- d. Aspartate aminotransferase and ALT < 3 × ULN;
- For patients with inactive/asymptomatic carriers, chronic or active HBV infection, the following criteria must be met:
- HBV DNA < 500 IU/mL (or 2500 copies/mL) during screening;
- Note: Patients with positive hepatitis B surface antigen or detectable HBV DNA should be managed according to treatment guidelines. Patients receiving antiviral therapy during screening must have undergone treatment for > 2 weeks prior to enrollment;
- Female patients of childbearing potential must voluntarily agree to use highly effective contraception during the study period, for ≥ 120 days after the last dose of camrelizumab or placebo, and for ≥ 180 days after the last dose of chemoradiotherapy, and must have a negative urine or serum pregnancy test result within ≤ 7 days prior to enrollment;
- Male patients who are not sterilized must voluntarily agree to use highly effective contraception during the study period, for ≥ 120 days after the last dose of camrelizumab or placebo, and for ≥ 180 days after the last dose of chemoradiotherapy.
Who cannot join
- Here is the translation of the exclusion criteria into English:
- History of other malignancies;
- History of fistula caused by primary tumor infiltration;
- Patients at high risk of esophageal fistula or with signs of esophageal perforation;
- History of esophageal cancer surgery;
- Poor nutritional status, with BMI less than 18.5 kg/m², or PG-SGA score ≥ 9;
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- Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to randomization);
- Known intolerance or resistance to the chemotherapy regimen specified in the study protocol;
- Prior receipt of any other anti-tumor therapy for ESCC (e.g., therapies targeting PD-1, PD-L1, PD-L2, or other tumor immunotherapies, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor treatments);
- Patients with active autoimmune disease or a history of autoimmune disease that may relapse;
- Note: Patients with the following conditions are not excluded and may proceed to further screening:
- Controlled type I diabetes; b. Hypothyroidism (controlled with hormone replacement therapy only); c. Controlled celiac disease; d. Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia); e. Any other disease that is not expected to relapse in the absence of external triggers; k. Presence of other active malignancies within ≤ 2 years prior to enrollment, except for the specific cancer under study in this trial and locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast); l. Any condition requiring systemic treatment with corticosteroids (dose > 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within ≤ 14 days prior to randomization;
- Note: Patients who have currently or previously used any of the following steroid regimens are not excluded:
- Adrenal replacement steroids (prednisone ≤ 10 mg/day or equivalent); b. Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; c. Short-term (≤ 7 days) prophylactic use of corticosteroids (e.g., for prevention of contrast agent allergy) or for treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reaction caused by contact allergens); m. Presence of uncontrolled diabetes, laboratory test abnormalities for potassium or sodium > Grade 1 despite standard medical therapy, or hypoalbuminemia ≥ Grade 3 within ≤ 14 days prior to enrollment; n. History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases including pulmonary fibrosis, acute lung diseases, etc.; o. Presence of severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy (including tuberculosis infection, etc.) within 14 days prior to enrollment; Note: Patients with chronic HBV or HCV infection are permitted to receive antiviral therapy; p. Known history of HIV infection; q. Major surgery performed within ≤ 28 days prior to enrollment; Note: Minimally invasive procedures (e.g., peripherally inserted central catheter [PICC]) are not considered major surgery; r. Prior allogeneic stem cell transplantation or organ transplantation; s. Presence of any of the following cardiovascular risk factors:
- Cardiac chest pain occurring within ≤ 28 days prior to randomization, defined as moderate pain limiting instrumental activities of daily living;
- Symptomatic pulmonary embolism occurring within ≤ 28 days prior to randomization;
- Acute myocardial infarction occurring within ≤ 6 months prior to randomization;
- History of heart failure reaching New York Heart Association (NYHA) Class III or IV within ≤ 6 months prior to randomization;
- Ventricular arrhythmia ≥ Grade 2 occurring within ≤ 6 months prior to randomization;
- Cerebrovascular accident occurring within ≤ 6 months prior to randomization;
- Uncontrolled hypertension despite antihypertensive medication, i.e., systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, within ≤ 28 days prior to randomization;
- Syncope or seizure occurring within ≤ 28 days prior to randomization;
- History of severe hypersensitivity reaction to other monoclonal antibodies or to cisplatin or paclitaxel; u. Receipt of any chemotherapy, immunotherapy (e.g., interleukins, interferons, thymosins, etc.), or any investigational treatment within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug; v. Use of herbal medicines for cancer control within 14 days prior to the first dose of study drug; w. Patients with toxicities from prior anti-tumor therapy that have not recovered to baseline or stable levels, unless considered as adverse events without safety risks (e.g., alopecia, neuropathy, specific laboratory abnormalities); x. Receipt of live vaccine within ≤ 28 days prior to randomization; Note: Seasonal influenza vaccines are typically inactivated vaccines and are permitted. Intranasal vaccines are live vaccines and are not permitted; y. Presence of underlying diseases (including laboratory abnormalities), alcohol or substance abuse or dependence that may interfere with study drug administration, affect interpretation of drug toxicity or adverse events, or compromise the patient's compliance with study procedures; z. Concurrent participation in another therapeutic clinical trial; aa. Other factors that, in the investigator's judgment, may necessitate premature termination of the study participation (e.g., prisoners or individuals under involuntary detention; individuals detained involuntarily for treatment of psychiatric or physical illnesses such as infectious diseases).
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
Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research
Nanjing, Jiangsu, 210000
Ning Jiang, +86 13605184783, njiang117@njmu.edu.cn
About this study
Official title: Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma: A Prospective, Multicenter, Multi-Cohort Phase II Clinical Study (STELLAR01)
This study aims to compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in the treatment of locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.
Read the detailed description
The RTOG 8501 trial established definitive chemoradiotherapy (dCRT) as the standard treatment for patients with locally advanced unresectable esophageal cancer. Although long-term survival and even cure have been observed in a subset of patients treated with dCRT, the overall short- and long-term outcomes remain unsatisfactory. For example, the complete response (CR) rate after dCRT is only approximately 25%, most patients eventually experience local recurrence or distant metastasis, and the 5-year overall survival rate is only about 20%. Therefore, there remains a substantial unmet medical need for improving the treatment of patients with locally advanced unresectable esophageal cancer.In patients with unresectable esophageal cancer, several small-sample exploratory studies have investigated the combination of immunotherapy with dCRT. The EC-CRT-001 study preliminarily demonstrated that dCRT combined with toripalimab achieved a CR rate of 62% and a 1-year overall survival rate of 78.4% in patients with locally advanced unresectable esophageal squamous cell carcinoma. A study by Zhao et al. explored induction chemo-immunotherapy followed by concurrent chemoradiotherapy, reporting a 1-year overall survival rate of 88.0% and a 2-year local control rate of 81.7%, which were also superior to those reported in traditional studies of chemoradiotherapy alone. Taken together, these findings suggest that the incorporation of immune checkpoint inhibitors (ICIs) into definitive chemoradiotherapy-based multimodal treatment may improve outcomes in patients with locally advanced unresectable esophageal squamous cell carcinoma.Currently, several large randomized controlled trials, such as RATIONALE 311 and KUNLUN, are ongoing to evaluate the efficacy of immunotherapy maintenance following concurrent chemoradiotherapy compared with placebo. However, the optimal integration strategy of chemoradiotherapy and immunotherapy remains unclear. In lung cancer, the PACIFIC trial established the cornerstone role of immunotherapy maintenance in patients with unresectable stage III disease. In esophageal cancer, other studies such as SKYSCRAPER-07 are also investigating the efficacy and safety of immunotherapy maintenance following definitive chemoradiotherapy. Nevertheless, which combination strategy of conventional chemoradiotherapy and ICIs can best balance efficacy and toxicity remains to be elucidated and warrants further clinical investigation.Based on this background, the present study aims to investigate and compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in patients with locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.
- Being tested
- Camrelizumab
- Keywords
- esophageal carcinoma, Definitive Chemoradiotherapy, immunotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabBiological
Also called nab-paclitaxel + carboplatin, short-course definitive radiotherapy
This study aims to compare the efficacy and safety of two novel treatment strategies-short-course definitive chemoradiotherapy combined with adjuvant camrelizumab, and short-course definitive chemoradiotherapy combined with concurrent plus adjuvant camrelizumab-in patients with locally advanced unresectable esophageal squamous cell carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy | Experimental | Nab-paclitaxel plus carboplatin will be administered every 3 weeks as one cycle, for a total of two cycles, concurrently with camrelizumab immunotherapy and radiotherapy (45 Gy in 18 fractions, 5 days per week, D3-D26). After completion of concurrent chemoradiotherapy plus immunotherapy, the decision to add two cycles of adjuvant chemotherapy will be made based on a comprehensive assessment of the patient's physical condition and other relevant factors. Patients will receive camrelizumab as maintenance therapy every 3 weeks for up to 12 months (a total of 17 cycles), or until disease progression, unacceptable toxicity, investigator decision, or withdrawal of consent by the patient. Receives: Biological: Camrelizumab |
| short-course definitive chemoradiotherapy plus immunotherapy maintenance | Experimental | Nab-paclitaxel plus carboplatin will be administered every 3 weeks as one cycle, for a total of two cycles, concurrently with radiotherapy (45 Gy in 18 fractions, 5 days per week, D3-D26). After completion of concurrent chemoradiotherapy, the decision to add two cycles of adjuvant chemotherapy will be made based on an overall assessment of the patient's physical condition and other relevant factors. Patients will receive camrelizumab as maintenance therapy every 3 weeks for up to 12 months (a total of 17 cycles), or until disease progression, unacceptable toxicity, investigator decision, or withdrawal of consent by the patient. Receives: Biological: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Progression- Free Survival
1-year progression-free survival (PFS) defined as the probability from study enrollment to tumor progression (in any aspect) or death from any cause within 1 year.
Measured: from study enrollment to tumor progression (in any aspect) or death from any cause within 1 year.
Secondary outcomes (4)
complete response rate
Complete response rate at 3 months after completion of radiotherapy: assessed by CT, high-resolution MRI and/or PET-CT, in combination with endoscopic ultrasound-guided bite-on-bite biopsy.
Measured: 3 months after completion of radiotherapy
treatment-related adverse events
Grade ≥3 treatment-related adverse events will be recorded according to CTCAE version 5.0 during the treatment period, from study enrollment until 90 days after the final administration of chemoradiotherapy.
Measured: from study enrollment until 90 days after the final administration of chemoradiotherapy
Overall Survival
Defined as from date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 100 months
Measured: From study enrollment to death from any cause, assessed up to 100 months
Duration of Response
From the time of first response to disease progression or death from any cause, whichever came first, assessed up to 100 months
Measured: From the time of first response to disease progression or death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable Esophageal Squamous Cell CarcinomaStudies 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
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ning Jiang, M.D./Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ning Jiang, M.D./Ph.D., Jiangsu Cancer Institute & Hospital
- Investigators
- Xiangzhi Zhu, Study director, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530094
- Sponsor's protocol ID
- STELLAR01
- Acronym
- STELLAR01
- Status last verified
- Dec 2025
- First submitted
- 1 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma: A Prospective, Multicenter, Multi-Cohort Phase II Clinical Study (STELLAR01)
- ClinicalTrials.gov ID
- NCT07530094
- Acronym / sponsor ID
- STELLAR01 / STELLAR01
- Keywords
- esophageal carcinoma, Definitive Chemoradiotherapy, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Ning Jiang, M.D./Ph.D.University, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 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 study aims to compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in the treatment of locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.
Detailed description
The RTOG 8501 trial established definitive chemoradiotherapy (dCRT) as the standard treatment for patients with locally advanced unresectable esophageal cancer. Although long-term survival and even cure have been observed in a subset of patients treated with dCRT, the overall short- and long-term outcomes remain unsatisfactory. For example, the complete response (CR) rate after dCRT is only approximately 25%, most patients eventually experience local recurrence or distant metastasis, and the 5-year overall survival rate is only about 20%. Therefore, there remains a substantial unmet medical need for improving the treatment of patients with locally advanced unresectable esophageal cancer.In patients with unresectable esophageal cancer, several small-sample exploratory studies have investigated the combination of immunotherapy with dCRT. The EC-CRT-001 study preliminarily demonstrated that dCRT combined with toripalimab achieved a CR rate of 62% and a 1-year overall survival rate of 78.4% in patients with locally advanced unresectable esophageal squamous cell carcinoma. A study by Zhao et al. explored induction chemo-immunotherapy followed by concurrent chemoradiotherapy, reporting a 1-year overall survival rate of 88.0% and a 2-year local control rate of 81.7%, which were also superior to those reported in traditional studies of chemoradiotherapy alone. Taken together, these findings suggest that the incorporation of immune checkpoint inhibitors (ICIs) into definitive chemoradiotherapy-based multimodal treatment may improve outcomes in patients with locally advanced unresectable esophageal squamous cell carcinoma.Currently, several large randomized controlled trials, such as RATIONALE 311 and KUNLUN, are ongoing to evaluate the efficacy of immunotherapy maintenance following concurrent chemoradiotherapy compared with placebo. However, the optimal integration strategy of chemoradiotherapy and immunotherapy remains unclear. In lung cancer, the PACIFIC trial established the cornerstone role of immunotherapy maintenance in patients with unresectable stage III disease. In esophageal cancer, other studies such as SKYSCRAPER-07 are also investigating the efficacy and safety of immunotherapy maintenance following definitive chemoradiotherapy. Nevertheless, which combination strategy of conventional chemoradiotherapy and ICIs can best balance efficacy and toxicity remains to be elucidated and warrants further clinical investigation.Based on this background, the present study aims to investigate and compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in patients with locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy | Experimental | Biological: CamrelizumabNab-paclitaxel plus carboplatin will be administered every 3 weeks as one cycle, for a total of two cycles, concurrently with camrelizumab immunotherapy and radiotherapy (45 Gy in 18 fractions, 5 days per week, D3-D26). After completion of concurrent chemoradiotherapy plus immunotherapy, the decision to add two cycles of adjuvant chemotherapy will be made based on a comprehensive assessment of the patient's physical condition and other relevant factors. Patients will receive camrelizumab as maintenance therapy every 3 weeks for up to 12 months (a total of 17 cycles), or until disease progression, unacceptable toxicity, investigator decision, or withdrawal of consent by the patient. |
| short-course definitive chemoradiotherapy plus immunotherapy maintenance | Experimental | Biological: CamrelizumabNab-paclitaxel plus carboplatin will be administered every 3 weeks as one cycle, for a total of two cycles, concurrently with radiotherapy (45 Gy in 18 fractions, 5 days per week, D3-D26). After completion of concurrent chemoradiotherapy, the decision to add two cycles of adjuvant chemotherapy will be made based on an overall assessment of the patient's physical condition and other relevant factors. Patients will receive camrelizumab as maintenance therapy every 3 weeks for up to 12 months (a total of 17 cycles), or until disease progression, unacceptable toxicity, investigator decision, or withdrawal of consent by the patient. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- The patient or their legal representative is able to sign the written informed consent form and understands and agrees to comply with the study requirements;
- Age ≥ 18 years and < 75 years at the time of signing the informed consent form, regardless of gender;
- Histologically confirmed esophageal squamous cell carcinoma, confirmed by imaging examinations such as CT, MRI, or PET-CT as locally advanced unresectable ESCC (medically unsuitable for surgery or refusal of surgical intervention), and suitable for cCRT, including: stages II-IVa and certain cases of stage IVb (involving only supraclavicular lymph node metastasis) (AJCC version 8 ) meeting the criteria;
- Estimated life expectancy of at least 6 months;
- ECOG performance status score of 0-2;
Key exclusion criteria (23 listed)
- History of other malignancies;
- History of fistula caused by primary tumor infiltration;
- Patients at high risk of esophageal fistula or with signs of esophageal perforation;
- History of esophageal cancer surgery;
- Poor nutritional status, with BMI less than 18.5 kg/m², or PG-SGA score ≥ 9;
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 |
|---|---|---|
| CamrelizumabAlso: nab-paclitaxel + carboplatin, short-course definitive radiotherapyThis study aims to compare the efficacy and safety of two novel treatment strategies-short-course definitive chemoradiotherapy combined with adjuvant camrelizumab, and short-course definitive chemoradiotherapy combined with concurrent plus adjuvant camrelizumab-in patients with locally advanced unresectable esophageal squamous cell carcinoma. | Biological | short-course definitive chemoradiotherapy plus immunotherapy maintenance, short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy |
Primary outcome
1-year Progression- Free Survival
Time frame: from study enrollment to tumor progression (in any aspect) or death from any cause within 1 year.
1-year progression-free survival (PFS) defined as the probability from study enrollment to tumor progression (in any aspect) or death from any cause within 1 year.
4 secondary outcomes
complete response rate
Time frame: 3 months after completion of radiotherapy
treatment-related adverse events
Time frame: from study enrollment until 90 days after the final administration of chemoradiotherapy
Overall Survival
Time frame: From study enrollment to death from any cause, assessed up to 100 months
Duration of Response
Time frame: From the time of first response to disease progression or death from any cause, whichever came first, assessed up to 100 months
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 15 Apr 2026.
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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.
Xiangzhi Zhu study director
Jiangsu Cancer Institute & Hospital
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 Camrelizumab in people with Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, run by Ning Jiang, M.D./Ph.D. 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 17 inclusion and 23 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 15 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 Xiangzhi Zhu (+86 25 83283535, 13182948068@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Progression- Free Survival (time frame: from study enrollment to tumor progression (in any aspect) or death from any cause within 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 15 Apr 2026.