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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| PD-1 inhibitor +/- chemotherapy alone | Active Comparator | Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor+/- chemotherapy combined with local therapy | Combination Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| treatment related side effect |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Liu, MD | Contact | 86-18017317882 | 18017317882@163.com | |
| Kuaile Zhao, MD | Contact | 86-18017312534 | kuaile_z@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Kuaile Zhao, MD | Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai cancer center | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40734507 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| 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) |
|
|
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 |
| 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 |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |