TABLE 11.
Characteristics of the randomized controlled trials evaluating other adjuvant therapies
| Study (reference) | Adjuvant protocol and number of patients |
Patients’ baseline characteristics
|
|||
|---|---|---|---|---|---|
| Tumour characteristics | Liver disease | Follow-up | |||
| Cancer vaccine therapy | |||||
| Kuang et al (59) | Study arm: intradermal injection of autologous formalin-fixed tumour vaccine for 3 courses (one course consisted of 5 injections of the tumour vaccine followed by a two-week interval); n=18 Control arm: no adjuvant therapy; n=21 |
TNM stage I–IIIA; single tumour 95%; tumour size ≥5 cm 51%; intrahepatic metastasis or vascular invasion 33% | C-P A 92%; cirrhosis 54%; HBV 90% | Median 15 months | |
| Internal radiation therapy | |||||
| Lau et al (60, 61) | Study arm: transhepatic arterial infusion of iodine 131-labelled lipiodol (1850 MBq) for one time; n=21 Control arm: no adjuvant therapy; n=22 |
Median tumour size 4.4 cm for study arm and 3.8 cm for control arm; vascular invasion 5% | Okuda stage I–II; HCV 88% | Median 34.6 or 66 months | |
| Antibody targeted radioimmunotherapy | |||||
| Xu et al (62) | Study arm: iv hLicartin*† 15.4 MBq/kg for 3 times (28-day intervals); n=30 Control arm: the same dosage of placebo; n=30 |
TNM stage III–IV; single lesion with tumour size >5 cm 72%; multiple lesion with tumour size >3 cm 28%; portal vein cancer thrombi 45% | C-P A 43%; cirrhosis 100%; HBV 88% | Median 12.3 months | |
| Heparanase inhibitor PI-88 therapy | |||||
| Liu et al (63) | Study arm 1: subcutaneous injection of PI-88 160 mg/day for 9 courses (one course consisted of consecutive 4 days of daily PI-88 for 3 weeks and a one-week interval); n=56 Study arm 2: PI-88 250 mg/day given with the same protocol as arm 1; n=54 Control arm: no adjuvant therapy; n=58 |
Single tumour 85%; mean tumour size 4.9 cm for study arm 1, 5.1 cm for study arm 2 and 5.5 cm for control arm; vascular invasion 23% | C-P A 96%; cirrhosis 56%; HBV 73% | 379–381 days | |
*
Iodine 131-labelled metuximab (HAb18 F[ab′]2).
†
Chengdu Hoist Hitech Co Ltd, China; and the Fourth Military Medical University, Xi’an, China. C-P Child Child-Pugh class; iv Intravenous.