Neoadjuvant PD-1 blockade for elderly patients with 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 phase 2 study evaluates the safety and efficacy of toripalimab, a PD-1 blockade therapy, as a neoadjuvant treatment for elderly patients over 75 years old with locally advanced resectable esophageal squamous cell carcinoma. The study aims to address the lack of evidence-based treatment strategies for this age group, as current guidelines primarily focus on younger patients. Participants will receive the treatment prior to surgery, with the goal of improving surgical outcomes and overall survival rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects signed the informed consent and volunteered to participate in the study.
2. Esophageal squamous cell carcinoma confirmed by histology or cytology.
3. Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as T1N1-3M0 or T2-3N0-3M0 (M1 lymph node metastasis confined to the supraclavicular lymph nodes) (AJCC 8th).
4. Expect to have R0 resection
5. In age \>75.
6. ECOG PS: 0\~1.
7. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
8. No contraindications to surgery.
9. Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5.
10. Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to five months after last administration.
11. Good compliance, willing to comply with follow-up schedules.

Exclusion Criteria:

1.Subjects have received or are receiving any of:

1. anti-tumor interventions such as radiotherapy, chemotherapy, immunotherapy or other medictions.
2. Received systemic corticosteroid therapy (prednisone equivalence\> 10mg/d) or other immunosuppressive agents within the first 2 weeks prior to the first administration.
3. live vaccine within 4 weeks before the first administration.

2\. Cancer related exclusion criteria

1. other cancers instead of ESCC
2. non-recetable or metastatic ESCC
3. not comply with T1N1-3M0 or T2-3N0-3M0 (AJCC 8th).
4. Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, and localized prostate cancer received radical surgery in situ that have received radical treatment and do not need other treatment can be included).

3\. Other criteria Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrthymia that needs treatment Subjects with any known active autoimmune disease Pregnant or breastfeeding female Presence of allergy or hypersensitivity to investigational medications HIV positive or active hepatitis B (HbsAg positive and HBV-DNA ≥2000 IU/ml or ≥ 104 copies/mL) or active hepatitis C (HCV antibody positive) or active tuberculosis Investigators assessed there might be other factors that cause subjects to withdrawl.

Where it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zhigang Li, MD, PhD
• Email: zhigang.li@shsmu.edu.cn
• Phone: 86-18960619260

Similar studies

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

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  This trial will test whether giving toripalimab together with low‑dose capecitabine after definitive chemoradiotherapy helps people with locally advanced esophageal squamous cell carcinoma live longer and have fewer recurrences.

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• PF-08098488 in adults with advanced solid tumors

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  Recruiting at 4 sites Phase 1 Pfizer · Grand Rapids, Michigan and 3 other locations · NCT07903415

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

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

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• Modular Robot-Assisted Esophagectomy vs. Conventional Minimally Invasive Esophagectomy for Esophageal Cancer

  This trial tests whether modular robotic-assisted esophagectomy using the Carina platform works better than conventional 3D thoracoscopic esophagectomy for people with resectable esophageal cancer.

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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.