Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

NCT07530094 | Recruiting Phase 2

• 1 other identifier: STELLAR01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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 carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.

Conditions

Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Keywords

esophageal carcinoma; Definitive Chemoradiotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  from study enrollment to tumor progression (in any aspect) or death from any cause within 1 year.

Secondary Outcomes (4)

• complete response rate

  3 months after completion of radiotherapy

• treatment-related adverse events

  from study enrollment until 90 days after the final administration of chemoradiotherapy

• Overall Survival

  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

Study Arms (2)

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.

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.

Biological: Camrelizumab

Interventions

Camrelizumab BIOLOGICAL

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.

Also known as: nab-paclitaxel + carboplatin, short-course definitive radiotherapy

short-course definitive chemoradiotherapy plus immunotherapy maintenance; short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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;

You may not qualify if:

• 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;
• 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:
• a. 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:
• a. 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;

Sponsors & Collaborators

• Ning Jiang, M.D./Ph.D.: lead

Study Sites (1)

Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumab; 130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Xiangzhi Zhu

  Jiangsu Cancer Institute & Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiangzhi Zhu

CONTACT

+86 25 83283535; 13182948068@163.com

Ning Jiang

CONTACT

+86 25 83283535; njiang117@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Jiangsu Cancer Institute & Hospital

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 15, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2025-12

Locations

CN (1)