Neoadjuvant PD-1 blockade for elderly patients with esophageal cancer

Neoadjuvant PD-1 Blockade (Toripalimab) Monotherapy for Elderly Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: a Phase II Trial

This study is testing a new treatment for older patients with esophageal cancer to see if it can help them have better surgery results and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 76 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone, toripalimab, atezolizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06385730 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly patients aged over 75 with locally advanced resectable esophageal squamous cell carcinoma.

Not a fit: Patients with esophageal cancer who have previously received anti-tumor treatments or those with contraindications to surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective neoadjuvant option for elderly patients with esophageal cancer, potentially improving their surgical outcomes and survival rates.

How similar studies have performed: While there is limited evidence specifically for elderly patients, similar immunotherapy approaches have shown promise in younger populations, indicating potential for success in this novel application.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhigang Li, MD, PhD

Conditions Esophageal Cancer; esophageal cancer, immunotherapy, elderly patients