China Cancer Trials (B13, B14)

Lead Research Organisation: Medical Research Council

Abstract

B13. Qidong Hepatitis B Vaccine Trial (80,000 children randomised during 1985-9 with long-term follow-up on morbidity and mortality from chronic liver disease and liver cancer) To assess long-term effects on morbidity and mortality from liver disease of early vaccination, with and without booster at age 2-3, against hepatitis B virus (HBV). Neonatal vaccination produced reductions in chronic HBV infection at age 5-6 at age 10-11. The booster at age 2-3 had little effect on either the positive rate of HBsAg or the incidence of chronic active hepatitis. It has already had a major impact on the introduction of a nationwide vaccination program against HBV in China. Continued follow-up of study participants will document the effect of vaccination on liver cancer incidence and mortality and help understand chronic liver disease. B14. Chinese Colorectal Cancer Trial (11,000 colorectal cancer patients randomised between 5-FU portal vein infusion vs control in 1994-98 with follow-up to 2007) To assess whether, among colorectal cancer patients with no evidence of liver metastases, a 7-day course of chemotherapy directly into the portal vein can improve long-term survival. During the hospital stay, there was an excess of mortality in the 5-FU group . In 2006 there was no significant difference between the 5-FU and control groups in the survival rate at 5 years or 10 years. These results show that 1-week of intraportal 5-FU for colorectal cancer produced little apparent survival benefit.

Technical Summary

B13. Qidong Hepatitis B Vaccine Trial (80,000 children randomised during 1985-9 with long-term follow-up on morbidity and mortality from chronic liver disease and liver cancer) Objectives: To assess long-term effects on morbidity and mortality from liver disease of early vaccination, with and without booster at age 2-3, against hepatitis B virus (HBV). Design: A cluster randomised trial by area of birth with open label HBV vaccination. Techniques: 80,000 infants born in China during 1985-90 randomised by area of birth between control and 5ug of open label HBV vaccine at 0, 1 and 6 months of age. At age 2-3 years, vaccinated children further allocated to receive either 5 ug booster, 10 ug booster or no booster. Measurements: Baseline information on children, details of vaccination and blood samples from both child and mother. At ages 5-6 and 10-11, a proportion of children from both groups bled again, to determine HBV-related markers and liver enzymes. A small subset of children further tested at age 13-16 for these markers. All children followed up for chronic liver disease, mortality from liver cancer and other liver disease. Main findings: Neonatal vaccination produced proportional reductions in chronic HBV infection of 72% at age 5-6 and of 79% at age 10-11. At these two ages, the proportion of children with chronic active hepatitis was only one fifth as great in those who had been vaccinated as in those who had not. The booster at age 2-3 significantly increased the proportion of children who tested positive for anti-HBs, but had little effect on either the positive rate of HBsAg or the incidence of chronic active hepatitis. Implications: One of the largest HBV vaccine trials in the world, its findings have already had a major impact on the introduction of a nationwide vaccination program against HBV in China. Continued follow-up of study participants will document the effect of vaccination on liver cancer incidence and mortality and help understand the natural history of chronic liver disease which may lead to improved early diagnosis of the condition. B14. Chinese Colorectal Cancer Trial (11,000 colorectal cancer patients randomised between 5-FU portal vein infusion vs control in 1994-98 with follow-up to 2007) Objectives: To assess whether, among apparently resectable colorectal cancer patients with no evidence of liver metastases, a 7-day course of chemotherapy directly into the portal vein can improve long-term survival. Design: A randomised open-controlled trial. Techniques: A trial involving 200 hospitals in China. Eligible patients randomised peri-operatively to receive surgery alone vs surgery plus portal vein infusion (PVI) of 5-fluorouracil (5-FU) continuously, at a fixed dose of 1g/day, for one-week immediately after operation. All comparisons were by intention-to-treat and used the log-rank method. Measurements: Demographic and clinical data collected at baseline for each patient. The primary outcome for assessing the effects of a 7-day PVI of 5-FU was long-term survival. Main findings: During the hospital stay, there was a small but definite excess of mortality in the 5-FU group . In 2006, 5174 patients were known to have died and there was no significant difference between the 5-FU and control groups in the survival rate at either 5 years or 10 years. These results show that, contrary to the previous meta-analysis of small trials, 1-week of intraportal 5-FU for colorectal cancer produced little apparent survival benefit.

Publications


10 25 50
 
Description Press coverage for report on Smoking and all-cause mortality in China 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Global press release attracting significant print and online media coverage on the following paper "Contrasting male and female trends in tobacco-attributed mortality in China: evidence from successive nationwide prospective cohort studies. Lancet 2015; 386:1447-56 (doi: 10.1016/S0140-6736(15)00340-2)."

Typical Headline: "Smoking set to kill one in three young men in China"
Year(s) Of Engagement Activity 2015,2016
 
Description Radio Interview on Smoking 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact National Radio Interveiw onfor BB Scotland on Smoking and Mortality paper in China
Year(s) Of Engagement Activity 2016
 
Description TV Interview 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact TV interview conducted online for China Central TV in Beijing - on predicted effects of smoking on mortality in China
Year(s) Of Engagement Activity 2016