Table 3.
Preliminary results summary.
| Principal Investigator Study Identifier |
Nb of Patients | Inclusion Criteria | Study Design | Treatment Details | Primary Endpoint | Primary Endpoint Results |
|---|---|---|---|---|---|---|
| Neoadjuvant Treatment | ||||||
| Cheng, Chao ChiCTR2000028900 |
20 | ESCC | Phase II | Carboplatin/Paclitaxel Camrelizumab |
pCR | 27.8% |
| Li, Jingpei NCT04225364 |
56 | ESCC | Phase II | Nabpaclitaxel/Cisplatin Camrelizumab | pCR | 35.3% |
| Li, Zhigang ChiCTR1900026240 |
60 | ESCC | Phase II | Carboplatin/Paclitaxel Camrelizumab |
pCR | 42.5% |
| Wang, Feng NCT03917966 |
26 | ESCC | Phase II | Nedaplatin/Docetaxel Camrelizumab |
Major pathologic response, pCR | 42% major response 25% pCR |
| Wang, Zhen ChiCTR1900023880 |
30 | ESCC | Phase Ib | Chemotherapy (Nabpaclitaxel/Platin/Apatinib) Camrelizumab |
Safety and feasibility | 80% patients received all planned cycles, 36.7% serious adverse effects |
| Zhao, Lingdi NCT 03985670 |
30 | ESCC | Phase II | Simultaneous versus sequential chemo-immunotherapy (Paclitaxel/Cisplatin+ Toripalimab) |
pCR | 36.4% sequential versus 7.7% simultaneous, p = 0.079 |
| Safran, Howard NCT01196390 |
203 | EAC, HER2 (+) |
Phase III, RCT |
Carboplatin/Paclitaxel + 50.4Gy +/− Transtuzumab |
DFS OS |
Median DFS: 19.6 mo (CR/T) versus 14.2 mo (CR), p = 0.85 |
| Yamamoto, Shun NCT03914443 FRONTiER |
13 | ESCC | Phase I | 5FU/Cisplatin Nivolumab |
toxicity pCR |
50% ≥ grade 3 adverse events 33.3% pCR |
| Zhang Z ChiCTR1900026593 |
40 | ESCC | Phase II | Carboplatin/Paclitaxel Sintilimab |
Major pathologic response | 47.5% major response 25% pCR |
| Perioperative-Adjuvant Treatment | ||||||
| Al-Batran SE NCT03421288 DANTE trial |
40 | Gastro-EAC | Phase II | FLOT [8] Perioperative Atezolizumab + adjuvant Atezolizumab |
Adverse events | 80% in arm FLOT-A, 70% in arm FLOT |
| Eads, Jennifer NCT03604991 |
31 | EAC | Phase I RCT |
Carboplatin/Paclitaxel + 41.4Gy Perioperative Nivolumab |
Safety, side effects | No disproportionate toxicity added by Nivolumab |
| YuyatKu, Geoffrey NCT02962063 |
36 | EAC | Phase I/II | 5FU/platin + 50.4Gy Perioperative Darvolumab |
pCR | pCR 24% |
| Mamdani Hirva NCT02639065 |
24 | EAC | Phase II | 5FU/Cisplatin + radiation Adjuvant Darvolumab |
Toxicity | 12.3% ≥ grade 3 adverse events |
| Athauda, Avani NCT03399071 ICONIC |
15 | EAC | Phase II/I | FLOT [8] Perioperative Avelumab |
Treatment-related toxicity R0 rate |
60% Grade 3–4 toxicity 100% R0 |
ESCC = Esophageal Squamous cell carcinoma, EAC = esophageal adenocarcinoma, RCT = Randomized Controlled Trial. pCR = pathologic complete response.