Combining PD-1 inhibitor with chemoradiotherapy and surgery for esophageal cancer

Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)

This study is testing if adding a new drug to standard treatment before surgery can help people with advanced esophageal cancer live longer and feel better.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 422 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: sintilimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05357846 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a PD-1 inhibitor, sintilimab, when combined with preoperative chemoradiotherapy and surgery in patients with locally advanced squamous cell esophageal carcinoma. The study compares this combination treatment to standard neoadjuvant chemoradiotherapy followed by surgery, focusing on overall survival rates. Eligible participants include those with specific stages of esophageal cancer who have not received prior anticancer therapies. The trial will assess the potential benefits of this innovative approach in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with resectable stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

Not a fit: Patients who have received prior anticancer therapy or cannot tolerate surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve overall survival rates for patients with locally advanced esophageal cancer.

How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in combination with chemoradiotherapy, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
2. Patients must not have received any prior anticancer therapy.
3. More than 6 months of expected survival.
4. Age ranges from 18 to 70 years.
5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
6. WHO PS score 0-1
7. Signed informed consent document on file.

Exclusion Criteria:

1. Patients have received any prior anticancer therapy.
2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
3. Patients with concomitant hemorrhagic disease.
4. Patients who cannot tolerate surgery.
5. Pregnant or breast feeding.
6. Patients without informed consent because of psychological, family, social or any other factors.
7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
10. Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
11. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
12. Patients with history of interstitial lung disease or noninfectious pneumonia.
13. Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
14. Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: HONG YANG — Sun Yat-Sen University Cancer Center
• Study coordinator: HONG YANG, M.D. Ph.D.

Conditions: Squamous Cell Esophageal Carcinoma, Esophageal Cancer, Oesophageal Cancer