pISSN 2636-0004eISSN 2636-0012
pISSN 2636-0004Results of Clinical Trials of Immunotherapy Combined with Local Therapy in the Late-Line Treatment of pMMR/MSS mCRC
| Study name | |||||||
|---|---|---|---|---|---|---|---|
| Fruquintinib + tislelizumab + SBRT (FRIUT) | Fruquintinib + sintilimab + RT | PD-1 inhibitor + RT + GM-CSF | Ipilimumab + nivolumab + RT (C2D1) | Ipilimumab + nivolumab + RT (C1D1) | Durvalumab + tremelimumab + RT | Durvalumab + tremelimumab + RFA/SBRT | |
| Publish time | 2023 ASCO-GI | 2023 AACR | 2022 ASCO | 2022.5.18 | 2023 ASCO | 2021.1.27 | 2023 ASCO-GI |
| MSI status | MSS | MSS | MSS | MSS | MSS | MSS | MSS |
| Line of therapy | ≥ Third-line | ≥ Third-line | - | ≥ Third-line | ≥ Third-line | ≥ Third-line | ≥ Third-line |
| PS status | - | - | - | 0 (65%)/1 (35%) | 0/1 | 0 (25%)/1 (75%) | - |
| Regimen | Fruquintinib (5 mg, QD, PO, day 1–14); tislelizumab (200 mg, day 1, IV); SBRT (8–10 Gy × 5 F, QOD) | Fruquintinib (QD, PO, day 1–14); anti-PD-1 (200 mg, day 1, IV); patients with isolated or localized metastasis will receive RT | RT (5 or 8 Gy × 2–3 F) for one metastatic lesion, PD-1 inhibitor dosing within 1 week RT, GM-CSF 200 μg subcutaneous injection QD for 14 days (day 1–14), or GM-CSF 200 μg (day 1–7), and then followed by IL-2200 million IU SC QD for 7 days (day 8–14) | Ipilimumab (1 mg/kg every 6 weeks for the first 4 cycles); nivolumab (240 mg every 2 weeks on a 6-week cycle); RT with 24 Gy/3 fractions to one site starting on C2D1 | Ipilimumab (1 mg/kg every 6 weeks for the first 4 cycles); nivolumab (240 mg every 2 weeks on a 6-week cycle); RT with 24 Gy/3 fractions to one site starting on C1D1 | Durvalumab 1,500 mg plus tremelimumab 75 mg every 4 weeks plus RT | Tremelimumab 75 mg and durvalumab 1,500 mg for 4 cycles followed by durvalumab 1,500 mg every 4 weeks During cycle 1, RFA and SBRT were performed concurrently |
| Enrolled number | 23 | 25 | 9 | 27 | 30 | 24 | 21 |
| ORR (%) | 26 | 28.0 | 22.2 | 15 | 13 | 8.3 | - |
| DCR (%) | 83 | 80.0 | 66.7 | 37 | 33 | - | - |
| mPFS (mo) | 5.1 | 6.05 | 5.6 | 2.5 | 2.4 | 1.8 | - |
| mOS (mo) | Not reach | - | - | 10.9 | 10.6 | 11.4 | 2.2 |
RT, radiation therapy; SBRT, stereotactic body radiation therapy; SIRT, selective internal radiation therapy; SABR, stereotactic ablative radiotherapy; CRT, conventional radiotherapy