Table 2
Studies investigating the combination of radiotherapy and immune checkpoint inhibitors in esophageal squamous cell carcinoma.
| First author | Time | Country | Type | No. of patients (all, each groups) | Inclusion criteria | Enrollment time | Treatment strategy | Local treatment | Radiation dose | Systemic treatment | Treatment regimens | Primary endpoints | Secondary endpoints | Efficacy (same order as “Treatment Strategy”) | Toxicity |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Qi Liu (ESO-Shanghai 13, NCT03904927) | 2023 | China | Pase II, RCT, Multicentered | 104 (53/51) | Oligometastasis (1–4 metastatic lesions. 1–3 anatomical sites, longest diameter ≤ 5 cm), Primary tumor treated definitively without progression > 3 months, PS 0–1, SCC | 2019–2021 | Local + Systemic vs. Systemic | SBRT > Thermal ablation > conventional R > S | Metastases: SBRT (BED > 80 Gy, except for bone metastases): Lung (central) 50y/5f, Lung (peripheral)/Liver/Adrenal gland/Abdominal lymph node 48 Gy/6f, Bone/Vertebral body 30 Gy/3f Conventional R: Abdominal lesions 45–50 Gy/25–28f, Cervical and thoracic lesions 50–66 Gy/25–34f | C/I ± C | Chemotherapy First-line: paclitaxel + cisplatin Second-line: docetaxel/irinotecan/Others Immunotherapy: anti-PD-1 antibody | PFS | OS, Local control, Toxicity, Quality of life | mPFS: 15.3 m vs. 6.4 m, p < 0.0001 mOS: Not reached vs. 18.6, p = 0.0020 Local control: 83% vs. 26% Median duration of local control: Not reached vs. 6.1 m, p < 0.0001 | ≥G3: 47% vs. 41%, p = 0.538 Leukocytopenia: 49% vs. 47%, G3 4% vs. 8%, G4 28% vs. 27% Pneumonitis: 21% vs. 14%, G3–4 0 vs. 0, G5 0 vs. 2% Esophagitis: 21% vs. 2%, G3 2% vs. 0, G4 0 vs. 0 Treatment-related death: 4% (Esophageal fistula) vs. 2% (Pneumonitis) |
| Wensi Zhao (ChiCTR2000040533) | 2023 | China | Phase II, Prospective, Single-arm, Double-centered | 49 | First-line I + C failure, PS 0–2, SCC | 2018–2021 | R + C + I | Low dose R | Primary tumor: 40 Gy/20f Metastases: 30 Gy/10f | I + C | Camrelizumab + Irinotecan | PFS | OS, ORR, DCR, CBR, Toxicity, ARR, ACR | mPFS: 6.9 m mOS: 12.8m ORR: 40.8% DCR: 75.5% ARR: 34.7% ACR: 69.4% | Any: 100%, ≥G3: 63.3% Leukopenia: 79.6%, ≥G3 30.6% Radiation-induced pneumonia: 10.2%, ≥G3 6.1% Radiation-induced esophagitis: 20.4%, ≥G3 4.1% |
| Xiaoyue Wu | 2022 | China | Retrospective, Controlled, Single-centered | 127 (40/87) | Metastatsis or Recurrence, KPS ≥ 70, SCC | 2017–2021 | R + I ± C vs. I ± C | R/SBRT | Conventional R (48%): 50–60 Gy/25–33f SBRT (8%): 36–50 Gy/4–6f Palliative R (44%): 30–48 Gy/10–24f | I ± C | Immunotherapy: Pembrolizumab/Nivolumab/Camrelizumab/Sintilimab/Tislelizumab Chemotherapy: Docetaxel/Taxane/Platinum/Fluoropyrimidine/Irinotecan | PFS, OS | Improvement of dysphagia, Toxicity | mPFS: 5.45 m vs. 4.60 m, p = 0.660 mOS: 11.9 m vs. 10.3 m, p = 0.890 Improvement of dysphagia: 64% vs. 30%, p = 0.033 | Leukopenia: 65% vs. 36%, p = 0.004; ≥G3 8% vs. 5%, p = 0.805 |
| Pneumonitis: 8% vs. 5%, p = 0.805, ≥ G3 3% vs. 0%, p = 0.689 Radiation esophagitis: 53%, ≥G3 0 |
RCT = Randomized controlled trial, m = month, SCC = Squamous Cell Carcinoma, CCRT = Concurrent Chemoradiotherapy, R = Radiotherapy, S = Surgery, C = Chemotherapy, T = Targeted Therapy, I = Immunotherapy, PFS = Progression-Free Survival, OS = Overall Survival; CSS = Cancer-Specific Survival, ORR = Objective Response Rate, DCR = Disease Control Rate, CBR = clinical benefit rate, ARR = Abscopal response rate, ACR = abscopal control rate.
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