Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

NCT04435197 | Completed Phase 2

• 1 other identifier: RTS-010
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

Brief Summary

To investigate the safety and activity of preoperative pembrolizumab combined with chemoradiotherapy for resectable esophageal squamous cell carcinoma (ESCC) ,20 patients enrolled in Phase Ib PALACE-1(NCT03792347).The results showed that preoperative pembrolizumab with concurrent chemoradiotherapy was safe, did not delay surgery and induced a pCR in 55.6% of resected tumors. In this multicentre prospective study(PALACE-2),the investigators will evaluate the efficacy of preoperative pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Immunotherapy; Pathologic complete response; preoperative pembrolizumab with concurrent chemoradiotherapy; Disease-free Survival; Median overall survival

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  Pathologic complete response was defined as pT0N0M0

  1 month after resection

Secondary Outcomes (2)

• 3-year disease free survival

  3 years after resection

• Overall Survival (OS)

  5 years

Study Arms (1)

Arm A

EXPERIMENTAL

Arm 1: A: Pembrolizumab 200mg(100mg if weight less than 50kg) IV on days 1 and 22 B: Carboplatin (AUC=2) IV and paclitaxel (50mg/m²) IV on day 1,8,15,22,29. C: Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. D: Ivor-Lewis or McKeown esophagectomy The participants will receive preoperative A+B+C. 4-6 weeks after completion of preoperative therapy ，D will be performed if there is no contraindication.

Drug: Pembrolizumab Injection

Interventions

Pembrolizumab Injection DRUG

Pre-operative Pembrolizumab+chemoradiotherapy

Also known as: Keytruda

Arm A

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients approve and sign the informed consent

You may not qualify if:

• Patients with active autoimmune disease or history of autoimmune disease.
• Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
• Subjects with a history of symptomatic interstitial lung disease.
• History of allergy to study drug components.
• Women must not be pregnant or breast-feeding.
• Men with female partners (WOCBP) that are not willing to use contraception.
• Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy.
• Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events

Sponsors & Collaborators

• Ruijin Hospital: lead
• Fujian Medical University Union Hospital: collaborator
• Zhejiang University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (2)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (2)

• Zheng Y, Li C, Yu B, Zhao S, Li J, Chen X, Li H. Preoperative pembrolizumab combined with chemoradiotherapy for esophageal squamous cell carcinoma: Trial design. JTCVS Open. 2021 Nov 10;9:293-299. doi: 10.1016/j.xjon.2021.11.003. eCollection 2022 Mar.

  PMID: 36003437 DERIVED

• Li C, Zhao S, Zheng Y, Han Y, Chen X, Cheng Z, Wu Y, Feng X, Qi W, Chen K, Xiang J, Li J, Lerut T, Li H. Preoperative pembrolizumab combined with chemoradiotherapy for oesophageal squamous cell carcinoma (PALACE-1). Eur J Cancer. 2021 Feb;144:232-241. doi: 10.1016/j.ejca.2020.11.039. Epub 2020 Dec 26.

  PMID: 33373868 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Pathologic Complete Response

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hecheng Li, MD&PHD

  Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

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: Chair of thoracic department

Model Details: Participants will receive carboplatin (AUC=2) IV and paclitaxel (50mg/m²) IV on day 1,8,15,22,29. And radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. Participants will also receive pembrolizumab (2mg/kg) IV on days 1 and 22. Surgery will be performed within 4-6 weeks after completion of preoperative therapy.

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 17, 2020
• Study Start: August 11, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

CN (2)