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Table 2 Acute toxicity and cause of death

From: A phase I study on combined therapy with proton-beam radiotherapy and in situ tumor vaccination for locally advanced recurrent hepatocellular carcinoma

No

Age/gender

PBT dose/frac

Skin

Labo data-1

CalTUMP dose

Vital sign changes

Labo data-2

Cause of death

1

73/M

74 GyE/37f

G2

n.p.

1/10

I. None

Slight increase of CRP

HF due to HCC progression

II. 37.0-37.7 in 1–2 days

III. 37.1-37.5 in 1–2 days

2

55/M

74 GyE/37 f

G2

n.p.

1/10

I. 37.4 in 1 day

Slight increase of CRP

HF due to HCC progression

II. None

III. None

3

52/M

76.2 GyE/22 f

G2

Slight increase of SGOT, SGPT

1/10

I. 37.1 in 1 day

n.p.

n.p.

II. None

III. None

4

63/M

76.2 GyE/22 f

G2

n.p.

1/3

I. None

n.p.

HF due to HCC progression

II. None

III. 37.4-37.7 in 1–2 days

5

65/M

52.8 GyE/16 f

G2

Increase of Bil

1/3

I. None

Decrease of PT

HF due to HCC progression

II. None

III. None

6

65/M

87.6 GyE/27 f

G2

Increase of BUN, creat

1/3

I. None

n.p.

HF due to HCC progression

II. None

III. 37.4 in 1 day

7

59/M

76.2 GyE/22 f

G2

n.p.

1/1

I. 37.4 - 38.0 in 1 day

Slight increase of CRP

n.p.

II. 37.5 - 38.4 in 1 day

III. 37.7 in 1 day

8

72/M

76.2 GyE/22 f

G2

n.p.

1/1

I. None

n.p.

HF due to HCC progression

II. None

III. None

9

71/F

76.2 GyE/22 f

G2

n.p.

1/1

I. 37.0 in 1 day

Increase of SGOT, SGPT, γ-GTP, ALP, CRP

n.p.

II. 37.1 in 1 day

III. 37.8 on the same day

  1. (PBT: Proton beam radiotherapy, Dose/frac: Total dose/fraction number, Labo data-1: Laboratory data changes associated with PBT, Labo data-2: Laboratory data changes associated with CalTUMP injection, HF: Hepatic failure).