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Table 3
Ongoing studies investigating the combination of radiotherapy and immune checkpoint inhibitors.
| Identifier | Study start | Country | Type | Phase | Estimated enrollment | Inclusion criteria | Arms and interventions | Primary outcome | Secondary outcome |
|---|---|---|---|---|---|---|---|---|---|
| NCT06086457 | 2024 | China | RCT | III | 436 | Initial stage cIVB (AJCC 8th), ≤2 organ or distant lymph node, SCC | Radiotherapy arm: C + Camrelizumab + concurrent R (Primary tumor 50 Gy/25f) PD-1 inhibitor plus chemotherapy arm: C + Camrelizumab | OS | PFS, ORR, Toxicity, Quality of life, etc. |
| NCT06084897 | 2023 | China | RCT | II | 120 | Initial stage IVB (AJCC 8th) or recurrence, SCC | Consolidation Radiation: C + I → R (lymphnode metastasis 49.22 Gy/23f or 50 Gy/25f, organ metastasis 40.66 Gy/19f or 40 Gy/20f) Salvage Radiation: C + I → R after disease progression (Same dosage) | 1y-OS | mPFS, Toxicity, Quality of life, ctDNA |
| NCT05978193 | 2023 | China | RCT | II | 160 | Initial stage IVB (AJCC 8th), SCC | Experimental: C + I + R (Primary tumor + Metastases 2 Gy/2f, d1–2, Q3 W × 4 cycles) → R (Primary tumor 40–50 Gy/20–25f) starting from the 5th I cycle Active Comparator: C + I | PFS | OS, Toxicity |
| NCT05732662 | 2023 | China | Prospective Single-arm | II | 25 | Metastasis or recurrence, SCC | SBRT (24–50 Gy/8–12.5 Gy/3–4f) + Cadonilimab (10 mg/kg, q3w) | ORR | OS, PFS, Toxicity |
| NCT06138028 | 2023 | China | Prospective Single-arm | II/III | 90 | Stage IV, SCC | Sintilimab + C → R (residual lesions: 50 Gy/25f) | OS, PFS | ORR, Toxicity |
| NCT05624099 | 2023 | China | Prospective Single-arm | II | 75 | Stage IVA or oligometastatic stage IVB (AJCC 8th), SCC | Camrelizumab + C+R (50.4 Gy/28f) | ORR | OS, PFS |
| NCT05760391 (ESO-Shanghai 19) | 2023 | China | Prospective Single-arm | II | 100 | Unresectable or recurrent (precluded esophagectomy/definitive chemoradiation/distant metastatic disease), SCC | C + I → IMRT/SBRT | OS | PFS, DCR |
| NCT06190782 (ESO-Shanghai 20) | 2022 | China | RCT | III | 354 | Genuine oligometastatic disease (≤4 distant metastases, ≤3 metastatic lesions within 1 organ, maximum diameter ≤ 5 cm), SCC | Experimental: I ± C + R (SBRT: lung/liver/adrenal gland/celiac lymphnode 48 Gy/6f; spine 30 Gy/10f; brain 24 Gy/30f; IMRT [Esophageal lesion or lesion unsuitable of SBRT]: 50.4 Gy/28f/S/Radiofrequency/microwave ablation Active Comparator: I ± C | PFS | OS, Local control, Toxicity |
| NCT05626569 | 2022 | China | Prospective Single-arm | II | 40 | Oligometastatic disease (≤3 organs, ≤5 metastatic lesions), SCC | I → SBRT (Metastases: single dose ≥ 4 Gy, fractions ≤ 10, BED ≥ 50 Gy) | 1y-PFS | 1y-OS, ORR, Toxicity |
| NCT05512520 | 2022 | China | RCT | II | 126 | Stage IVB, SCC | Experimental: CCRT (Primary tumor 45–50.4 Gy/25–28f) → I Control: C + I | 1y-PFS | 1y-OS, ORR, Toxicity |
| NCT05547828 | 2022 | China | Prospective Single-arm | II | 20 | Stage IVB, SCC | Tislelizumab + C + R (Primary tumor + lymphnode metastasis: 40 Gy/20f) | ORR | DCR, PFS, OS, Toxicity |
| NCT05628610 | 2022 | China | RCT | II | 130 | ≥70, recurrent/metastatic/unresectable local-advanced, SCC | Experimental: Tislelizumab + R (50 Gy/30f) Control: Tislelizumab + C | ORR | PFS |
| ChiCTR2100046715 | 2021 | China | Prospective Single-arm | II | 30 | N3M1 (AJCC 8th), Oligometastatic disease (≤5 Metastatic lesions, ≤3 lesions in 1 organ), SCC | C + I → CCRT | PFS | ORR, DCR, OS, etc. |
| NCT04221893 | 2020 | United States | Prospective Single-arm | II | 28 | Metastatic gastrointestinal malignancy, I with overall response of progressive disease | R 30 Gy/5f | ORR | PFS, OS, local control, Toxicity, etc. |
RCT = Randomized controlled trial, SCC = Squamous Cell Carcinoma, CCRT = Concurrent Chemoradiotherapy, R = Radiotherapy, S = Surgery, C = Chemotherapy, I = Immunotherapy, PFS = Progression-Free Survival, OS = Overall Survival, ORR = Objective Response Rate, DCR = Disease Control Rate.
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