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

NCT ID: NCT05626569

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-10
• Study Completion Date: 2026-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 combined with SBRT for metastatic lesions

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.

Group Type: EXPERIMENTAL

PD-1 combined with SBRT

Intervention Type: 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.

Interventions

PD-1 combined with SBRT

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.

Intervention Type: DRUG

Other Intervention Names

SBRT

Eligibility Criteria

Inclusion Criteria

1. Eastern Cooperative Oncology Group performance status ≤ 2;

2. Histologically confirmed squamous cell carcinoma of the esophagus;

3. Diagnosed with stage IVB disease (according to UICC TNM version 8) with less than five metastatic lesions within three organs;

4. 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;

5. At least one metastatic lesions amenable to the delivery of SBRT;

6. Estimated life expectancy >4 months;

7. 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;

8. Ability to understand the study and sign informed consent.

Exclusion Criteria

1. Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment;

2. Patients with intracranial metastasis disease at diagnosis;

3. History of thoracic irradiation;

4. Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum;

5. Patients have spinal bone metastases combined with spinal cord compression;

6. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;

7. Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia;

8. Inability to provide informed consent due to psychological, familial, social, and other factors;

9. Female patients who are pregnant or during lactation;

10. 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;

11. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Mian XI

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mian Xi, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Mian Xi

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mian Xi, MD

Role: CONTACT

ximian@sysucc.org.cn

02087340540

Baoqing Chen, MD

Role: CONTACT

chenbq@sysucc.org.cn

02087340540

Facility Contacts

Baoqing Chen

Role: primary

chenbq@sysucc.org.cn

02087340540

References

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.

Reference Type: BACKGROUND

PMID: 32417405 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34188053 (View on PubMed)

Other Identifiers

2022-FXY-119

Identifier Type: -

Identifier Source: org_study_id