Table 1.
Overview of recent trials discussed in this review.
| Name | Trial Number (ClinicalTrials.gov Identifier or Other) | Tumor Type | Setting (Line) | Phase | Population | Treatment Arms | Status | Results (First) Posted |
|---|---|---|---|---|---|---|---|---|
| ATTRACTION-2 | NCT02267343 | Gastric + GEJ * adenocarcinoma | ≥3 | III | Asia | Nivolumab/Placebo | Active, not recruiting | 2 December 2017 |
| KEYNOTE-059 | NCT02335411 | Gastric + GEJ adenocarcinoma, cohort 3: CPS ≥ 1 | 1–≥3 | II | North and South America, Asia, Europe | Cohort 1: 3rd line, Pembrolizumab Cohort 2: 1st line, Cisplatin + 5-FU + Pembrolizumab Cohort 3: 1st line, Pembrolizumab |
Active, not recruiting | 10 May 2018 |
| JAVELIN-GASTRIC-300 | NCT02625623 | Gastric + GEJ adenocarcinoma | ≥3 | III | North and South America, Asia, Europe | Avelumab/chemotherapy (physician’s choice) | Active, not recruiting | 1 October 2018 |
| KEYNOTE-061 | NCT02370498 | Gastric + GEJ adenocarcinoma | 2 | III | North and South America, Asia, Europe | Pembrolizumab/Paclitaxel | Active, not recruiting | 20 November 2018 |
| CHECKMATE-649 | NCT02872116 | Gastric + GEJ adenocarcinoma | 1 | III | Unknown | Cohort 1: Ipilimumab + Nivolumab Cohort 2: Nivolumab + Chemotherapy Cohort 3: Chemotherapy (investigator’s choice) |
Active, not recruiting | Estimated May 2021 |
| KEYNOTE-062 | NCT02494583 | Gastric + GEJ adenocarcinoma, CPS ≥1, HER2-negative | 1 | III | North and South America, Asia, Europe | Cohort 1: Pembrolizumab Cohort 2: Pembrolizumab + Cisplatin + 5-FU/Capecitabine Cohort 3: Placebo + Cisplatin + 5-FU/Capecitabine |
Active, not recruiting | 1 June 2019 |
| JAVELIN-GASTRIC-100 | NCT02625610 | Gastric + GEJ adenocarcinoma, HER2-negative | 1 | III | North America, Asia, Europe, Australia | Avelumab maintenance/chemotherapy | Active, not recruiting | Estimated November 2019 |
| ANGEL | NCT03042611 | Gastric + GEJ adenocarcinoma | ≥3 | III | North America, Asia, Europe | Apatinib/Placebo | Active, not recruiting | 29 September 2019 |
| INTEGRATE-2 | NCT02773524 | Gastric + GEJ adenocarcinoma or undifferentiated carcinoma | ≥3 | III | North America, Asia, Australia | Regorafenib/Placebo | Recruiting | Estimated July 2020 |
| REGONIVO | NCT03406871 | Gastric, colorectal or hepatocellular cancer | ≥2 | Ib | Asia | Regorafenib + Nivolumab | Active, not recruiting | 2 July 2019 |
| REGARD | NCT00917384 | Gastric + GEJ adenocarcinoma | 2 | III | North and South America, Asia, Europe, Australia | Ramucirumab/Placebo | Completed | 4 January 2014 |
| RAINBOW | NCT01170663 | Gastric + GEJ adenocarcinoma | 2 | III | North and South America, Europe, Asia, Australia | Paclitaxel + Ramucirumab/Paclitaxel + Placebo | Completed | 1 October 2014 |
| BRIGHTER | NCT02178956 | Gastric + GEJ adenocarcinoma | 2 | III | North America, Asia, Europe, Australia | Napabucasin + Paclitaxel/Placebo + Paclitaxel | Completed | 20 May 2018 |
| EXPAND | EudraCT: 2007-004219-75 | Gastric + GEJ adenocarcinoma | 1 | III | Europe | Standard chemotherapy + Cetuximab/standard chemotherapy (investigator’s choice) | Completed | 15 April 2013 |
| REAL-3 | NCT00824785 | Oesophageal + gastric + GEJ adenocarcinoma or undifferentiated carcinoma | 1 | III | Europe | Epirubicin + Oxaliplatin + Capecitabine + Panitumumab/Epirubicin + Oxaliplatin + Capecitabine | Terminated (Lack of efficacy) | June, 2013 |
| RILOMET-1 | NCT01697072 | Gastric + GEJ adenocarcinoma, MET-positive | 1 | III | North and South America, Europe, Asia | Epirubicin + Cisplatin + Capecitabine + Rilotumumab/Epirubicin + Cisplatin + Capecitabine + Placebo | Terminated | November, 2017 |
| METGastric | NCT01662869 | Gastric + GEJ adenocarcinoma, HER2-negative, MET-positive | 1 | III | North America, Europe, Asia | 5-FU + Folinic acid + Oxaliplatin + Onartuzumab/5-FU + Folinic acid + Oxaliplatin + Placebo | Completed | 1 May 2017 |
| AVAGAST | NCT00548548 | Gastric + GEJ adenocarcinoma | 1 | III | North America, Europe, Asia | Cisplatin + 5-FU or Capecitabine + Bevacizumab/Cisplatin + 5-FU or Capecitabine + Placebo | Completed | 22 September 2016 |
| AVATAR | NCT00887822 | Gastric + GEJ adenocarcinoma | 1 | III | Asia | Cisplatin + 5-FU or Capecitabine + Bevacizumab/Cisplatin + 5-FU or Capecitabine + Placebo | Completed | 21 February 2014 |
| RAINFALL | NCT02314117 | Gastric + GEJ adenocarcinoma, HER2-negative | 1 | III | North and South America, Europe, Asia | Cisplatin + 5-FU or Capecitabine + Ramucirumab/Cisplatin + 5-FU or Capecitabine + Placebo | Active, not recruiting | 1 March 2019 |
| GAMMA-1 | NCT02545504 | Gastric + GEJ adenocarcinoma, HER2-negative | 1 | III | North America, Europe, Australia | Leucovorin + 5-FU + Oxaliplatin + Andecaliximab/Leucovorin + 5-FU + Oxaliplatin | Completed | 29 January 2019 |
| FAST | NCT01630083 | Oesophageal + gastric + GEJ adenocarcinoma, CLDN18.2 expression | 1 | II | Europe, Asia | Epirubicin + Oxaliplatin + Capecitabine + IMAB362/Epirubicin + Oxaliplatin + Capecitabine | Completed | 11 October 2016 |
| TAGS | NCT02500043 | Gastric + GEJ adenocarcinoma | 3 | III | North America, Europe, Asia | Trifluridine + Tipiracil/Placebo | Completed | 21 October 2018 |
| ABSOLUTE | JapicCTI-132059 | Gastric adenocarcinoma | 2 | III | Asia | Paclitaxel/Nab-Paclitaxel | Completed | April, 2017 |
| WJOG 4007 | UMIN000001252 | Gastric cancer | 2 | III | Asia | Paclitaxel/Irinotecan | Completed | December, 2013 |
| COUGAR-02 | ISRCTN13366390 | Gastric + GEJ + oesophageal adenocarcinoma | 2 | III | Europe | Docetaxel/active symptom control | Completed | 15 Janurary 2014 |
| FLOT4 | NCT01216644 | Gastric + GEJ adenocarcinoma, locally advanced (>T1) and/or nodal positive (N+) | 1 | II/III | Europe | Epirubicin + Cisplatin + 5-FU or Capecitabine (ECF/ECX)/5-FU + Leucovorin + Oxaliplatin + Docetaxel (FLOT) | Completed | 11 May 2019 |
| REGATTA | UMIN000001012 | Gastric cancer with a single non-curable factor | 1 | III | Asia | Oral S-1 + Cisplatin/Gastrectomy followed by oral S-1 + Cisplatin | Completed | March, 2016 |
| RENAISSANCE (AIO-FLOT5) | NCT02578368 | Limited metastatic gastric + GEJ adenocarcinoma | 1 | III | Europe | 5-Fluorouracil + Leucovorin + Oxaliplatin + Docetaxel (FLOT)/FLOT + gastrectomy | Recruiting | December, 2021 |
| TOGA | NCT01041404 | Gastric + GEJ adenocarcinoma, HER2-positive | 1 | III | Europe, Asia, Australia, Africa, South America | Cisplatin + 5-FU or Capecitabine/Cisplatin + 5-FU or Capecitabine + Trastuzumab | Completed | 28 August 2010 |
| LOGIC | NCT00680901 | Oesophageal + gastric + GEJ adenocarcinoma, HER2-positive | 1 | III | North and South America, Europe, Asia | Capecitabine + Oxaliplatin + Lapatinib/Capecitabine + Oxaliplatin + Placebo | Active, not recruiting | 10 February 2016 |
| JACOB | NCT01774786 | Gastric + GEJ adenocarcinoma, HER2-positive | 1 | III | North and South America, Europe, Asia | Cisplatin + 5-FU or Capecitabine + Trastuzumab + Pertuzumab/Cisplatin + 5-FU or Capecitabine + Trastuzumab + Placebo | Active, not recruiting | 11 September 2018 |
| GATSBY | NCT01641939 | Gastric + GEJ adenocarcinoma, HER2-positive | ≥2 | II/III | North and South America, Europe, Asia | Trastuzumab emtansine/Docetaxel or Paclitaxel | Terminated | 23 March 2017 |
| TyTAN | NCT00486954 | Gastric + GEJ adenocarcinoma, HER2-positive | 2 | III | Asia | Lapatinib plus Paclitaxel/paclitaxel | Completed | 1 July 2014 |
| KEYNOTE-811 | NCT03615326 | Gastric + GEJ adenocarcinoma, HER2-positive | 1 | III | Unknown | standard of care chemotherapy + Trastuzumab + Pembrolizumab/standard of care chemotherapy + Trastuzumab | Recruiting | Estimated August 2023 |
| KEYNOTE-181 | NCT02564263 | Oesophageal squamous cell carcinoma + adenocarcinoma | 2 | III | North America, Europe, Asia | Pembrolizumab/chemotherapy (physician’s choice) | Active, not recruiting | 2 July 2019 |
| CHECKMATE-473 | NCT02569242 | Oesophageal cancer | ≥2 | III | Unknown | Nivolumab/Docetaxel or Paclitaxel | Unknown | Estimated November 2019 |
| ATTRACTION-3 | NCT02569242 | Oesophageal squamous cell carcinoma | ≥2 | III | North America, Europe, Asia | Nivolumab/Docetaxel or Paclitaxel | Unknown | 30 September 2019 |
| KEYNOTE-590 | NCT03189719 | Oesophageal squamous cell carcinoma + adenocarcinoma | 1 | III | Unknown | Pembrolizumab + Cisplatin + 5-FU/Placebo + Cisplatin + 5-FU | Active, not recruiting | Estimated October 2021 |
| CHECKMATE-648 | NCT03143153 | Oesophageal squamous cell carcinoma | 1 | III | Unknown | Cohort 1: Ipilimumab + Nivolumab Cohort 2: Nivolumab + 5-FU + Cisplatin Cohort 3: 5-FU + Cisplatin |
Recruiting | Estimated July 2020 |
* GEJ = gastroesophageal junction.