Prospective Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With PD-1/PD-L1 Inhibitors in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

NCT06888531 | Active Not Recruiting Phase 2

• 1 other identifier: LA-ESCC-II-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective trial design was used to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors in the treatment of locally advanced resectable esophageal squamous cell carcinoma.

Conditions

Esophageal Malignant Neoplasm Primary

Keywords

LA-ESCC

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  pCR

  From enrollment to the end of treatment at 2 years

Secondary Outcomes (1)

• Major pathologic response

  From enrollment to the end of treatment at 2 years

Study Arms (1)

Treatment Group

EXPERIMENTAL

Toripalimab: intravenous infusion, 240mg, D1, Q3W, for 2 consecutive doses; or Envorimab: subcutaneous injection, 400mg, D1, Q3W, for 2 consecutive doses. Albumin-bound paclitaxel: intravenous infusion, 50mg/m2, D1, QW, for 5 consecutive doses. Carboplatin: intravenous infusion, AUC=2, D1, QW, for 5 consecutive doses. Radiotherapy: 41.4Gy/1.8Gy/23F, D1-5, 5 times per week.

Combination Product: Neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of locally advanced resectable esophageal squamous cell carcinoma

Interventions

Neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of locally advanced resectable esophageal squamous cell carcinoma COMBINATION_PRODUCT

Toripalimab: intravenous infusion, 240mg, D1, Q3W, for 2 consecutive doses; or Envorimab: subcutaneous injection, 400mg, D1, Q3W, for 2 consecutive doses. Albumin-bound paclitaxel: intravenous infusion, 50mg/m2, D1, QW, for 5 consecutive doses. Carboplatin: intravenous infusion, AUC=2, D1, QW, for 5 consecutive doses. Radiotherapy: 41.4Gy/1.8Gy/23F, D1-5, 5 times per week.

Also known as: LA-ESCC

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 75 years
• ECOG performance score 0-1
• Histologically or pathologically confirmed resectable thoracic esophageal squamous cell carcinoma, clinical stage T1b-2 N+ M0 or T3-4a anyN M0 (AJCC 8th)
• No prior anti-tumor treatment before surgery
• At least one measurable lesion (according to RECIST 1.1 criteria).
• Normal major organ function

You may not qualify if:

• Allergic to the treatment drugs
• Patients who have received or are currently receiving other chemotherapy, radiotherapy, immunotherapy or targeted therapy
• Patients with tumors that have invaded major blood vessels as shown by imaging or those judged by the investigator to be highly likely to invade major blood vessels and cause fatal hemorrhage during the subsequent study period
• Patients with other malignant tumors that require active treatment within 5 years of the study (except for those that have been adequately treated, such as basal cell or squamous cell skin cancer with an expected 5-year survival rate \> 90%, cervical carcinoma in situ, and ductal carcinoma in situ of the breast)
• Patients with active autoimmune diseases or immunodeficiency
• Patients who are currently using immunosuppressants or systemic hormones for immunosuppression purposes (dose \> 10mg/day of prednisone or other equivalent efficacy hormones) and have continued to use them within 2 weeks before enrollment
• Patients who have received systemic treatment with high-dose antibiotics within the past 2 weeks
• Patients who have experienced arterial or venous thrombotic events within 6 months before the first administration, including cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis and pulmonary embolism
• Patients with digestive tract diseases or conditions that may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis or unremoved gastrointestinal tumors with active bleeding, or other conditions judged by the investigator to be likely to cause gastrointestinal bleeding or perforation, and those with multiple factors affecting oral drug administration (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
• Patients with significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure with New York Heart Association (NYHA) classification ≥ 2; drug-treated ventricular arrhythmias (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women); left ventricular ejection fraction (LVEF) \< 50%
• Patients with active or uncontrolled severe infections (≥ CTCAE5.0 grade 2 infections), including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia, and unexplained fever \> 38.5°C before the first administration
• Patients with symptomatic pleural effusion, pericardial effusion or ascites that require frequent drainage as judged by the investigator
• Patients with liver cirrhosis or active hepatitis; for hepatitis B, HBsAg positive and HBV DNA exceeding the upper limit of normal (1000 copies/ml or 500 IU/ml); patients with a history of hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence of hepatitis B core antibody \[HBcAb\] and the absence of HBsAg, and normal HBV DNA value during the screening period can be included); for hepatitis C, HCV antibody positive and HCV viral load exceeding the upper limit of normal/HCV RNA or HCV Ab test indicating acute or chronic infection. 14. Patients with urine routine test indicating urine protein ≥++, and confirmed 24-hour urine protein quantification \> 1.0g

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital: collaborator

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 21, 2025
• Study Start: March 8, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-02

Locations

CN (1)