Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

NCT06190782 | Recruiting Phase 3

• 1 other identifier: ESO-Shanghai20
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone. The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.

Conditions

Esophageal Squamous Cell Carcinoma; Oligometastatic Disease; Radiotherapy

Keywords

esophageal squamous cell carcinom; Oligometastatic; Radiotherapy; pd-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone

  The time between the start of the study treatment(day 1) and progression disease(PD)

  3-year

Secondary Outcomes (3)

• overall survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone

  3-year

• treatment related side effect

  acute side effects within 3 months, late side effects for 3 months later

• local control rate

  1-year, 3-year

Study Arms (2)

PD-1 inhibitor+/- chemotherapy combined with local therapy

EXPERIMENTAL

Patients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy)

Combination Product: PD-1 inhibitor+/- chemotherapy combined with local therapy

PD-1 inhibitor +/- chemotherapy alone

ACTIVE COMPARATOR

Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy)

Drug: systemic therapy alone

Interventions

PD-1 inhibitor+/- chemotherapy combined with local therapy COMBINATION_PRODUCT

1. PD-1 inhibitor +/- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable First line: i. TP: paclitaxel 135-175mg/m2,d1+ DDP25mg/m2, d1-3 or 75mg/m2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives) 2. Local therapy i. Radiotherapy GTV=all suspected lesions. SBRT: for lung, liver, adrenal gland, celiac lymphnode metatstases 48Gy/6fx; for spine metastatic disease 30Gy/10Fx; for brain metastases 24Gy/30fx; IMRT: for bone metastatic disease 30Gy/10fx; for esophageal lesion or lesion unsuitable of SBRT 50.4Gy/28fx; ii. Surgery iii. Radiofrequency/microwave ablation

PD-1 inhibitor+/- chemotherapy combined with local therapy

systemic therapy alone DRUG

1.PD-1 inhibitor +/- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable First line: i. TP: paclitaxel 135-175mg/m2,d1+ DDP25mg/m2, d1-3 or 75mg/m2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives)

Also known as: the systemic therapy only

PD-1 inhibitor +/- chemotherapy alone

Eligibility Criteria

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

You may qualify if:

• \. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases

You may not qualify if:

• \. History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20\>25%

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai cancer center

Shanghai, China

RECRUITING

Related Publications (1)

• Mao G, Xin Z, Fan Q, Zhu H, Ye J, Zhou L, He Y, Xu B, Chen C, Li Z, Gu X, Li X, Wang X, Guo J, Xu Z, Wan P, Zhang Y, Zhang F, Huang C, Yi Q, Huang J, Liang S, Chen J, Lin Y, Fang Q, Chen Y, Ai D, Zhu H, Hao S, Liu Q, Zhao K. ESO-Shanghai 20: phase III clinical trial of anti-PD-1 therapy with local intervention for oligometastatic ESCC. Future Oncol. 2025 Aug;21(20):2575-2584. doi: 10.1080/14796694.2025.2534770. Epub 2025 Jul 30.

  PMID: 40734507 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

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

Study Officials

• Kuaile Zhao, MD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Qi Liu, MD

CONTACT

86-18017317882; 18017317882@163.com

Kuaile Zhao, MD

CONTACT

86-18017312534; kuaile_z@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: September 27, 2022
• Primary Completion: September 27, 2025
• Study Completion (Estimated): September 27, 2027
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

CN (1)