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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190782
• Other study ID #: ESO-Shanghai20
• Status: Recruiting
• Phase: Phase 3
• Start date: September 27, 2022
• Est. completion date: September 27, 2027

Study information

• Verified date: April 2024
• Source: Fudan University
• Contact: Qi Liu, MD
• Phone: 86-18017317882
• Email: 18017317882[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with oligometastatic squamous cell carcinoma were enrolled and 2:1 randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy (radiotherapy, surgery, radiofrequency/microwave ablation, etc.) or PD-1 inhibitor +/- chemotherapy alone. Different local therapy techniques are allowed to be used on different lesions in the same patient.All suspected malignant lesion should be included in local treatment planning in principle. The primary end point was progression-free survival (PFS). The second end points included overall survival, side effects and local control.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: September 27, 2027
• Est. primary completion date: September 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. =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

Exclusion Criteria:

• 1. 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%

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Oligometastatic Disease
• Radiotherapy

Intervention

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

Drug:
• systemic therapy alone
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)

Locations

Country	Name	City	State
China	Fudan University Shanghai cancer center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone	The time between the start of the study treatment(day 1) and death from an cause or last follow-up for patients alive at the end of the study	3-year
Secondary	treatment related side effect	Record the treatment related side effects including acute and late side effects	acute side effects within 3 months, late side effects for 3 months later
Secondary	local control rate	the portion of patients who do not develop progression disease or exacerbation of clinical symptoms despite stable disease	1-year, 3-year