Using Toripalimab after Chemoradiotherapy for Elderly Esophageal Cancer

Efficacy and Safety of Toripalimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma: a Multicenter, Randomized, Phase II Trial (EC-CRT-007)

This study is testing if the drug toripalimab can help older patients with advanced esophageal cancer feel better and lower their chances of the cancer coming back after they’ve had chemoradiotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 70 Years to 85 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: cadonilimab, chemotherapy, immunotherapy, toripalimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06187597 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of toripalimab, an anti-PD-1 antibody, as a consolidation therapy for elderly patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) following definitive chemoradiotherapy. A total of 140 patients aged 70 to 85 will be randomly assigned to receive either toripalimab for up to 12 months or no additional treatment after concurrent S-1 and radiotherapy. The study aims to improve clinical outcomes and reduce recurrence rates in this vulnerable population. Patients will be stratified based on age and disease stage to ensure appropriate treatment allocation.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 70 to 85 with unresectable locally advanced esophageal squamous cell carcinoma who have not received prior cancer therapy.

Not a fit: Patients with a history of previous malignancies or those who have been treated with anti-tumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for elderly patients with locally advanced esophageal cancer.

How similar studies have performed: Previous studies have shown promising results with the combination of immunotherapy and chemoradiotherapy in advanced esophageal cancer, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the esophagus;
2. Locally advanced, and absence of hematogenous metastasis disease according to UICC TNM version 8;
3. Not suitable for surgery (either for medical reasons or patient's choice);
4. Age at diagnosis 70 to 85 years;
5. No prior cancer therapy;
6. Estimated life expectancy \>6 months;
7. Eastern Cooperative Oncology Group performance status ≤ 2
8. No history of concomitant or previous malignancy;
9. The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥4.0×109/L, absolute neutrophil count (ANC) ≥1.5×109/L; b. platelets ≥100×109/L; c. hemoglobin ≥9g/dL; d. serum albumin ≥2.8g/dL; e. total bilirubin ≤1.5×ULN, ALT, AST and/or AKP ≤2.5×ULN; f. serum creatinine ≤1.5×ULN or creatinine clearance rate \>60 mL/min;
10. Ability to understand the study and sign informed consent.

Exclusion Criteria:

1. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
2. Patients with hematogenous metastasis disease or esophageal fistula at diagnosis;
3. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of cadonilimab, and the chemotherapeutic drugs paclitaxel or cisplatin;
4. Patients who have a preexisting or coexisting bleeding disorder;
5. Inability to provide informed consent due to psychological, familial, social and other factors;
6. Presence of CTC grade ≥2 peripheral neuropathy;
7. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
8. A history of diabetes for more than 10 years and poorly controlled blood glucose levels;
9. Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia.
10. Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;
11. A history of interstitial lung disease or non-infectious pneumonia;
12. A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
13. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).

Where this trial is running

Guangzhou, Guangdong

• Mian Xi — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Mian Xi, MD — Sun Yat-sen University
• Study coordinator: Mian Xi, MD

Conditions Locally Advanced Esophageal Squamous Cell Carcinoma; Esophageal squamous cell carcinoma; Chemoradiotherapy; Immunotherapy