Node-Sparing Short-Course Radiotherapy (25 Gy/5 Fractions) Combined With Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma：A Prospective Single-Arm, Phase II Study

NCT07808853 | Recruiting Phase 2 DMC

• 1 other identifier: 2026ZSLYEC-647
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-arm phase II study will evaluate the efficacy and safety of lymphatic-drainage-sparing short-course radiotherapy combined with camrelizumab and nab-paclitaxel/carboplatin as neoadjuvant treatment for patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma. Participants will receive three 3-week cycles of camrelizumab plus chemotherapy, with 25 Gy in 5 fractions of short-course radiotherapy delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Definitive McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy. The primary endpoint is pathologic complete response (ypT0N0).

Conditions

ESCC

Keywords

ESCC; short-course radiotherapy; lymphatic drainage sparing;neoadjuvant therapy; pCR

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR) Rate

  Percentage of participants undergoing definitive surgery who have no residual viable tumor in the resected primary tumor and regional lymph nodes, defined in the protocol as ypT0N0.

  At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.

Secondary Outcomes (5)

• Major Pathologic Response (MPR) Rate

  At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.

• Objective Response Rate (ORR)

  From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.

• R0 Resection Rate

  Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively

• Disease-Free Survival (DFS) Rate

  1 year and 3 years after surgery.

• Overall Survival (OS) Rate

  1 year and 3 years after surgery.

Study Arms (1)

Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin

EXPERIMENTAL

Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment.

Radiation: Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin

Interventions

Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin RADIATION

Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment. Drug: Camrelizumab Camrelizumab 200 mg intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Nab-paclitaxel Nab-paclitaxel 260 mg/m² intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Carboplatin Carboplatin AUC 5 intravenously on Day 1 of each 3-week cycle for 3 cycles. Radiation: Short-course radiotherapy 25 Gy in 5 fractions over 5 days, delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Procedure: McKeown esophagectomy McKeown esophagectomy with thoracoabdominal two-field lymph node dissection, planned 4-6 weeks after completion of neoadjuvant therapy (maximum extension of 2 additional

Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin

Eligibility Criteria

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

You may qualify if:

• Written informed consent before enrollment.
• Age 18 to 75 years, any sex.
• Treatment-naive esophageal squamous cell carcinoma confirmed by pathology and PET-CT.
• Clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (stage II/III according to the AJCC 9th edition).
• Disease assessed as amenable to R0 surgical resection before treatment.
• At least one measurable lesion according to RECIST v1.1.
• ECOG performance status 0-1.
• Adequate organ function: absolute neutrophil count ≥1,500/mm³; platelets ≥100,000/mm³; hemoglobin ≥9 g/dL; serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min; bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; no blood components or hematopoietic growth factors within 14 days.
• For women of childbearing potential: medically accepted contraception during treatment and for 3 months afterward; negative serum or urine HCG within 7 days before enrollment; not breastfeeding.
• For men who are not surgically sterile: agreement to use medically accepted contraception with their partner during treatment and for 3 months afterward.
• Willingness to participate and comply with safety and survival follow-up.

You may not qualify if:

• Prior radiotherapy, chemotherapy, prolonged/high-dose corticosteroid therapy, surgery, or molecular targeted therapy.
• Previous or concurrent other malignancy.
• Prior PD-1/PD-L1 therapy; known allergy to macromolecular protein preparations or any component of PD-1 therapy.
• Active autoimmune disease or relevant autoimmune disease history as specified in the protocol.
• Immunosuppressive agents for immunosuppression within 2 weeks before enrollment.
• Symptomatic pleural or peritoneal effusion requiring therapeutic puncture or drainage.
• Poorly controlled clinically significant cardiac disease as specified in the protocol.
• Abnormal coagulation with bleeding tendency or thrombolytic/anticoagulant therapy.
• Recent gastrointestinal conditions associated with bleeding or perforation risk.
• Severe bleeding within 3 months, hemoptysis within 4 weeks, or thromboembolic event within 12 months according to protocol thresholds.
• Active infection or unexplained fever \>38.5°C during screening or before first dose.
• Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.
• History/current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction.
• Congenital/acquired immunodeficiency including HIV infection, or active hepatitis outside protocol-defined limits.
• Participation in another clinical study or completion of a previous clinical study within 1 month; anticipated need for other systemic anticancer therapy.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guanzhou, Guangdong, 510655, China

RECRUITING

Related Publications (2)

• van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.

  PMID: 22646630 BACKGROUND

• Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6.

  PMID: 23374478 BACKGROUND

Related Links

• Simon's Two-Stage design

MeSH Terms

Conditions

Pathologic Complete Response

Interventions

camrelizumab; 130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Hongying Liao MD, Professor / Chief Physician, MD and PhD

CONTACT

+86-020-35919121; liaohy2@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Thoracic Surgery

Model Details: All enrolled participants receive the same neoadjuvant regimen followed by planned McKeown esophagectomy. A Simon optimal two-stage design is used for the primary pCR endpoint.

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 9, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-08

Locations

CN (1)