Anti-PD-1 Immunotherapy Combined With SBRT for Patients With Oligometastatic ESCC

NCT05626569 | Unknown Phase 2 DMC

• 1 other identifier: 2022-FXY-119
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase II clinical trial is to explore the efficacy and safety of anti-PD1 combined with stereotactic body radiation therapy (SBRT) for patients with oligometastatic esophageal squamous cell carcinoma. Participants will receive anti-PD1 and SBRT to the metastatic lesions which are amenable to the delivery of SBRT after 4\~6 cycles of systemic chemotherapy and anti-PD-1.

Conditions

Esophageal Squamous Cell Carcinoma; Oligometastatic Disease

Keywords

esophageal cancer; oligometastases; PD-1; SBRT

Outcome Measures

Primary Outcomes (1)

• 1-year progression-free survival

  1-year progression-free survival

  From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 12 months

Secondary Outcomes (3)

• 1-year overall survival

  From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 12 months

• ORR

  3 months after SBRT (plus or minus 14 days)]

• Treatment-related adverse events

  From the start of treatment to 2 year after the completion of treatment

Study Arms (1)

PD-1 combined with SBRT for metastatic lesions

EXPERIMENTAL

Participants will receive anti-PD1 and SBRT to the metastatic lesions which are amenable to the delivery of SBRT after 4\~6 cycles of systemic chemotherapy and anti-PD-1. SBRT for the metastatic lesions shall be conducted within two months after the completion of systemic therapy. The prescription of SBRT is determined by the investigator and the BED is required to over 50Gy.

Drug: PD-1 combined with SBRT

Interventions

PD-1 combined with SBRT DRUG

Anti-PD1 monoclonal antibody combined with SBRT. The SBRT defined as the radiation prescription with single dose equal or over 4Gy and the fractions less or equal to 10 fractions. BED equal or over 50Gy is required.

Also known as: SBRT

PD-1 combined with SBRT for metastatic lesions

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group performance status ≤ 2;
• Histologically confirmed squamous cell carcinoma of the esophagus;
• Diagnosed with stage IVB disease (according to UICC TNM version 8) with less than five metastatic lesions within three organs;
• Received 4 to 6 cycles of standard chemotherapy (fluoropyrimidine or taxane-based platinum doublet chemotherapy) and anti-PD1 treatment, and no progression disease was confirmed;
• At least one metastatic lesions amenable to the delivery of SBRT;
• Estimated life expectancy \>4 months;
• The function of important organs meet the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate \>60 mL/min;
• Ability to understand the study and sign informed consent.

You may not qualify if:

• Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment;
• Patients with intracranial metastasis disease at diagnosis;
• History of thoracic irradiation;
• Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum;
• Patients have spinal bone metastases combined with spinal cord compression;
• A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
• Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia;
• Inability to provide informed consent due to psychological, familial, social, and other factors;
• Female patients who are pregnant or during lactation;
• Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;
• A history of interstitial lung disease or non-infectious pneumonia; Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Mian Xi

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (2)

• Liu Q, Zhu Z, Chen Y, Deng J, Ai D, Liu Q, Wang S, Wu S, Chen J, Zhao K. Phase 2 Study of Stereotactic Body Radiation Therapy for Patients with Oligometastatic Esophageal Squamous Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):707-715. doi: 10.1016/j.ijrobp.2020.05.003. Epub 2020 May 14.

  PMID: 32417405 BACKGROUND

• Liu S, Luo L, Zhao L, Zhu Y, Liu H, Li Q, Cai L, Hu Y, Qiu B, Zhang L, Shen J, Yang Y, Liu M, Xi M. Induction chemotherapy followed by definitive chemoradiotherapy versus chemoradiotherapy alone in esophageal squamous cell carcinoma: a randomized phase II trial. Nat Commun. 2021 Jun 29;12(1):4014. doi: 10.1038/s41467-021-24288-1.

  PMID: 34188053 BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mian Xi, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mian Xi, MD

CONTACT

02087340540; ximian@sysucc.org.cn

Baoqing Chen, MD

CONTACT

02087340540; chenbq@sysucc.org.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: MD

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 23, 2022
• Study Start: December 10, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)