Review Article

Immunotherapy in Gastrointestinal Cancers

Table 1

Ongoing studies on gastric, gastroesophageal junction, and esophageal cancers.

NCT identifierSettingPhaseStudy interventionsNumber of patientsPrimary endpoint

Checkpoint inhibitors
NCT02689284Metastatic HER2+ GC/GEJCIb/IIMargetuximab+ pembrolizumab52MTD and MAD for margetuximab; duration of response; 12-month ORR
NCT02563548Metastatic GC after 1st lineIbPEGPH20 +pembrolizumab81DLT; 18-month ORR
NCT02443324Metastatic GC/GEJC and other tumoursIRamucirumab + pembrolizumab155DLT
NCT02589496Metastatic GC/GEJC after first lineIIPembrolizumab402-year RR
NCT02901301First-line HER2 + GCIb/IIPembrolizumab + trastuzumab + capecitabine + cisplatin49RP2D; 6-week ORR
NCT02954536First-line HER2+ GC/GEJC/ECIIPembrolizumab + trastuzumab + capecitabine + cisplatin376-month PFS
NCT02318901Unresectable HER2 + GC/GEJCIIPembrolizumab + ado-trastuzumab emtansine90RP2D
NCT02559687EC (adenocarcinoma or squamous cell)/GEJC after 2nd lineIIPembrolizumab1002-year ORR
NCT02494583First-line GC/GEJCIII (random)Pembrolizumab versus pembrolizumab + cisplatin + 5-fluorouracil or capecitabine versus placebo + cisplatin + 5-FU or capecitabine75044-month PFS and OS
NCT02370498Second-line GC/GEJCIII (random)Pembrolizumab versus paclitaxel720PFS, OS
NCT02564263EC (adenocarcinoma or squamous cell) /GEJC after 1st lineIII (random)Pembrolizumab versus investigator's choice of standard therapy (paclitaxel, docetaxel, or irinotecan)6003-year PFS and OS
NCT02872116Unresectable GC/GEJCIII (random)Nivolumab + ipilimumab versus nivolumab + oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine126640-month OS in patients PD-L1 +
NCT02864381Metastatic GC/GEJCII (random)GS-5745 + nivolumab versus nivolumab alone1202-year ORR
NCT02340975Pretreated metastatic/GC/GEJCIb/II (random)MEDI4736 + tremelimumab versus MEDI4736 versus tremelimumab135Phase Ib: DTL,
Phase II: ORR and 6-month PFS
NCT026256233rd-line GC/GEJCIII (random)Avelumab+ BSC versus chemotherapy (paclitaxel or irinotecan)+BSC or BSC alone3302-year OS
NCT026256101st-line GC/GEJCIII (random)Maintenance with avelumab versus continuation of 1st-line chemotherapy6663-year OS and PFS

Immunotherapy + radiotherapy
NCT026428091st-line ECIPembrolizumab + brachytherapy15Tolerability and toxicity
NCT02830594Pretreated EC/GC(GEJCIIPembrolizumab + external beam palliative radiation therapy14Biomarkers
NCT02735239Metastatic ECI/IIDurvalumab + oxaliplatin/capecitabine75AE, DLT, laboratory evaluations
Vaccines
NCT02276300Metastatic HER 2 + GCIHER2-derived peptide vaccination12Safety and tolerability
NCT02317471Stage III gastric cancerI/IIVaccination with autologous tumour derived heat shock protein gp9645DFS
NCT02795988Metastatic HER 2 + GC/GEJCIb/IIIMU-131 HER2/Neu peptide vaccine+ cisplatin and either 5-FU or capecitabine chemotherapy18RP2D, AE
Cytokines
NCT01691664Locally advanced ECNS (random)Radiation therapy alone or with DC-CIK cellular therapy40DFS
NCT01691625Locally advanced ECNS (random)Concurrent chemoradiation with or without DC-CIK50Quality of life
NCT02504229Metastatic refractory GCII
(random)
Chemotherapy with or without DC-CIK80PFS
NCT01783951Metastatic refractory GCI/IIS-1 with or without DC-CIK30PFS

CAR-T cells
NCT02713984Metastatic refractory HER 2 + GCI/IIAnti-HER2 CAR-T cells60Toxicity
NCT02725125Metastatic refractory GCI/IIEPCAM-targeted CAR-T cells19DCR
NCT02617134Metastatic refractory MUC1+ GCI/IIAnti-MUC1 CAR-T cells20Toxicity
NCT02349724Metastatic refractory CEA+ GCIAnti-CEACAR-T cells75Toxicity
NCT02862028Metastatic refractory EGFR+ GCI/IIAnti-PD-1CAR-T cells20ORR, DCR, OS, PFS
NCT03013712Metastatic refractory EpCAM+ GC/ECI/IIAnti-EpCAMCAR-T cells60Toxicity

GC, gastric cancer; GEJC, gastroesophageal junction cancer; EC: esophageal cancer; NA, not assessed; MTD, maximum tolerated dose; MAD, maximum administered dose; DTL, dose limiting toxicity; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; DFS, disease-free survival; NS, not specified; RP2D, recommended dose of phase II; AE, adverse events; DCR, disease control rate; BSC, best supportive care; DCR disease control rate.