Using Toripalimab after Chemoradiotherapy for Elderly Esophageal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mian Xi
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Mian Xi, MD — Sun Yat-sen University
• Study coordinator: Mian Xi, MD
• Email: ximian@sysucc.org.cn
• Phone: 862087343385

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Toripalimab with Chemoradiotherapy for Esophageal Cancer

  This study is testing if adding a new drug called Toripalimab to standard chemotherapy and radiation can help people with locally advanced esophageal cancer respond better to treatment before surgery.

  Recruiting Phase 2 Nanfang Hospital, Southern Medical University · Guangzhou, Baiyun District · NCT06843889

• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

• Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer

  This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07896681

• Propranolol with Toripalimab and Platinum Chemo before/around surgery in NSCLC

  This study tests whether adding propranolol to toripalimab and platinum-based chemotherapy is safe and tolerable for people with resectable non-small cell lung cancer before surgery.

  Recruiting Phase 1 Second Xiangya Hospital of Central South University · Changsha, Hunan and 3 other locations · NCT07886229

• Neoadjuvant Cryo-Thermal Ablation with Toripalimab and Chemo for Resectable NSCLC

  This study tests whether using Cryo-Thermal Ablation before chemo-immunotherapy helps people with resectable NSCLC see better outcomes.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan and 8 other locations · NCT07855965

• Rimegepant plus toripalimab in advanced urothelial cancer after standard therapy

  This small, early-stage study tests whether combining rimegepant with toripalimab is safe and shows signs of activity in adults with advanced urothelial cancer that did not respond to prior treatment.

  Recruiting at 2 sites Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality and 1 other locations · NCT07835035

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.