Table 1.
Clinical trial overview
| Subject |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | |
| Age (years) | 56 | 68 | 77 | 74 | 69 | 58 | 84 | 68 | 72 | 66 | 55 | 66 |
| Gender | M | M | M | M | F | M | F | M | M | M | M | F |
| Race | W | AA | W | W | W | W | W | W | AA | W | W | W |
| ECOG PS | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 |
| Location of primary tumor | B/N | B | H/N | H/U | T | H | B | H | T | B/T | B/T | T |
| Primary tumor size (cc) | 10 | 25 | 23 | 19 | 8 | 18 | 8 | 6 | 57 | 17 | 53 | 22 |
| Extrapancreatic extension | Y | Y | N | Y | Y | Y | N | N | Y | Y | Y | Y |
| Lymph node involvement | Y | Y | N | Y | N | Y | N | Y | N | Y | Y | N |
| CA/SMA encasement | N | Y | N | N | N | N | N | N | Y | Y | Y | N |
| Liver metastases | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
| Tumor in other organs | N | N | kidney | lung | spleen | lung | N | N | Lu/Ki/Ad | lung | N | N |
| Tumor stagea | T2N1M1 | T4N1M1 | T2N0M1 | T2N1M1 | T2N0M1 | T2N1M1 | T2N0M1 | T2N1M1 | T4N0M1 | T2N1M1 | T4N1M1 | T2N0M1 |
| Cohort | 1 | 1 | 1 | 2 | 2 | 2 | 3 | 3 | 3 | 3 | 3 | 3 |
| Adenovirus dose (vp) | 1 × 1011 | 1 × 1011 | 1 × 1011 | 3 × 1011 | 3 × 1011 | 3 × 1011 | 1 × 1012 | 1 × 1012 | 1 × 1012 | 1 × 1012 | 1 × 1012 | 1 × 1012 |
| Chemotherapy regimen | FOL | G/A | none | G/A | FOL to G/A | FOL | G | G/A | FOLFIRI | FOL | FOL | FOLFIRI to FOLFOX to G/A |
| Status (as of 11/05/2020) | expired | expired | expired | expired | expired | expired | expired | alive | expired | alive | alive | alive |
| Number of grade >3 AEsb | 1 | 1 | 0 | 3 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Number of SAEsc | 0 | 0 | 0 | 0 | 0 | 0 | 1 poss | 0 | 0 | 0 | 0 | 0 |
| Tumor response at 9 months | PD | PD | ND | SD | SD | PD | SD | SD | PD | SD | PD | PD |
| Survival (months)d | 4.8 | 5.4 | 1.6 | 2.7 | 10.5 | 3.5 | 15.2 | 20.0 | 3.5 | 19.1 | 18.1 | 18.0 |
| Adenovirus DNA in blood | N | N | N | N | Y | N | Y | N | N | N | N | N |
| IL-12/INF-g/IP10 in serum | N/Y/Y | N/Y/Y | N/N/N | Y/Y/Y | Y/N/Y | N/N/Y | Y/Y/Y | Y/Y/Y | Y/Y/Y | N/Y/Y | N/Y/Y | N/Y/Y |
B, body; CA, celiac axis; CR, complete response; F, female; FOL, FOLFIRINOX; G, Gemzar; G/A, Gemzar/Abraxane; H, head; M, male; N, neck; ND, cannot be determined based on CT every 2–3 months; PD, progressive disease; PR, partial response; SD, stable disease; SMA, superior mesenteric artery; T, tail; U, uncinate process.
a
American Joint Committee on Cancer, Eighth Edition.
b
Grade ≥3 adverse events (AEs) through primary toxicity endpoint (day 21 after the adenovirus injection) and prior to the start of chemotherapy.
c
Serious AEs (SAEs) that were unexpected and judged to be possibly/probably/definitely related to the investigational treatment (through day 21).
d
At the time of manuscript preparation.