Table 3.
Clinical trials of perioperative immunotherapy for resectable EC.
| Trial registration | Phase | Type | Start and complete date | Enrollment | Arm | Drug | Intervention/treatment | Primary outcome measure |
| NCT03064490 | Phase II | AC | Oct. 2017 to May 2023 | 38 | Single arm | Pembrolizumab | Neoadjuvant period: pembrolizumab + NCRT (paclitaxel + carboplatin)Adjuvant period: pembrolizumab | PCR |
| NCT02844075 | Phase II | ESCC | Jan. 2017 to May 2022 | 18 | Single arm | Pembrolizumab | Neoadjuvant period: pembrolizumab + NCRT (paclitaxel + carboplatin)Adjuvant period: pembrolizumab | PCR |
| NCT02998268 | Phase II | AC | Mar. 2017 to Apr. 2025 | 42 | Double arms | Pembrolizumab | Arm A:Induction period: chemotherapy (paclitaxel + carboplatin)Neoadjuvant period: pembrolizumab + NCRT (paclitaxel + carboplatin)Adjuvant period: pembrolizumabArm B:Induction period: pembrolizumab + chemotherapy (paclitaxel + carboplatin)Neoadjuvant period: pembrolizumab + NCRT (paclitaxel + carboplatin)Adjuvant period: pembrolizumab | DFS |
| NCT04389177 | Phase II | ESCC | Jul. 2020 to Dec. 2024 | 50 | Single arm | Pembrolizumab | Neoadjuvant period: pembrolizumab + NCT (paclitaxel + cisplatin)Adjuvant period: pembrolizumab | MPR |
| NCT04089904 | Phase II | AC | Oct. 2019 to Feb. 2025 | 33 | Single arm | Pembrolizumab | Pembrolizumab alone | PCR |
| NCT04159974 | Phase II | AC | Sep. 2019 to Jun. 2024 | 56 | Double arms | Durvalumab andtremelimumab | Arm A:durvalumabArm B:durvalumab + tremelimumab | Safety and efficacy |
| NCT03490292 | Phase I/II | ESCC or AC | May 2018 to Mar. 2022 | 24 | Single arm | Avelumab | Neoadjuvant period: avelumab + NCRT (paclitaxel + carboplatin)Adjuvant period: avelumab | Part 1: DLTPart 2: PCR |
| NCT03399071 | Phase II | AC | Jul. 2017 to Aug. 2025 | 40 | Single arm | Avelumab | Neoadjuvant period: avelumab + NCT (FLOT)Adjuvant period: avelumab + adjuvant chemotherapy (FLOT) | PCR |
| - | - | ESCC | Apr. 2020 to Sep. 2020 | 24 | Single arm | Toripalimab | Neoadjuvant period: toripalimab + NCT (nab-paclitaxel + S-1)Adjuvant period: toripalimab + adjuvant chemotherapy (nab-paclitaxel + S-1) | MPR |
| NCT04437212 | Phase II | ESCC | Jul. 2020 to Dec. 2023 | 20 | Single arm | Toripalimab | Neoadjuvant period: toripalimab + NCRT (paclitaxel + cisplatin)Adjuvant period: toripalimab | MPR |
| NCT04280822 | Phase III | ESCC | Apr. 2020 to Mar. 2028 | 400 | Double arms | Toripalimab | Arm A:Neoadjuvant period: toripalimab + NCT (paclitaxel + cisplatin)Adjuvant period: toripalimabArm B:NCT (paclitaxel + cisplatin) | EFS |
The data in this table are based on the “clinicalTrials.gov” and “Chinese Clinical Trial Registry.” AC: Adenocarcinoma; DFS: Disease-free survival; DLT: Dose-limiting toxicity; EC: Esophageal cancer; EFS: Event-free survival; ESCC: Esophageal squamous cell carcinoma; FLOT: Docetaxel + oxaliplatin + leucovorin + fluorouracil; MPR: Major pathological response; NCRT: Neoadjuvant chemoradiotherapy; NCT: Neoadjuvant chemotherapy; PCR: Pathological complete response; -: Not found.