A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 (A Monoclonal Antibody With Antiangiogenic Features) In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer

OS was the duration from date of randomization to date of death due to any cause. For participants who are alive, overall survival was censored at the last contact. Death was determined from adverse event (AE) data where outcome was death or from follow-up contact data where the participant current status was death.

Time frame: From first randomization to date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization

Population: Full analysis set (FAS) included all randomized participants regardless of what treatment, if any, was received.

Patient reported outcomes (PROs) were assessed using the FACT-Hep. The FACT-Hep included the FACT-general (FACT-G) and a hepatobiliary module, it consisted of the 27-item FACT-G, which assessed generic health-related quality of life (HRQoL) concerns, and the 18-item hepatobiliary subscale (HS), which assessed disease-specific issues. The questionnaire used a 5 point Likert scale from '0' not at all to '4' very much regarding how much each item was present in the last 7 days; lower score indicated severer symptom. Eight of the items (lack of energy, pain, weight loss, back pain, fatigue, stomach pain/discomfort, nausea, and jaundice) made up the Fact Hepatobiliary Symptom Index (FHSI 8) were considered to be symptoms specific to hepatobiliary cancer.

Time frame: Screening, Cycle 1 Day1,8; Cycle >=2 Day1; End of treatment, survival follow-up up to 24 months after last participant randomization.

Population: FAS included all randomized participants regardless of what treatment, if any, was received.

DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included \>1 date, the first date was to be used. DR (in months) was calculated as the end date for DR minus date of first CR or PR that was subsequently confirmed plus 1 divided by 30.4. CR was defined as disappearance of all target lesions and non-target, if any. PR was defined as \>=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions.

Time frame: From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization

Population: Subgroup of participants with objective response. Since objective response was not assessed in any of the participants, ideally the number of participants analyzed field should be 0 and the reason was insufficient data available to conduct adequate analysis due to premature termination of the study.

Time frame: 1 hour (after start of infusion) on Day1 of Cycles 1, 2, 4, 6, and 8

Population: The pharmacokinetic (PK) concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.

Time frame: Cycle 1, 2, 4, 6, 8 Day 1 at 0 hour (pre-dose)

Population: The immunogenicity assessment consisted of all participants who had at least 1 sample on at least 1 day of immunogenicity assessment.

ORR was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1, relative to all randomized participants. CR were those that persisted on repeat imaging study more than or equal to (\>=) 4 weeks after initial documentation of response. PR was defined as \>=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were to be counted as non-responders in the assessment of ORR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR, was to be assigned a best response of CR.

Time frame: Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.

Population: FAS included all randomized participants regardless of what treatment, if any, was received.

Time frame: Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.

Population: FAS included all randomized participants regardless of what treatment, if any, was received.

DCR was defined as the proportion of participants with confirmed CR or confirmed PR or a best response of stable disease (SD) \>=16 weeks according to RECIST, relative to all randomized participants. CR was defined as disappearance of all target lesions. PR was defined as \>=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

Time frame: From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization

Population: FAS included all randomized participants regardless of what treatment, if any, was received.

Tumor molecular characteristics including but not limited to transcriptomic (RNA) signatures of sensitivity

Time frame: Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.

Population: FAS included all randomized participants regardless of what treatment, if any, was received.

PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included \>1 date, the first date was to be used. PFS (in months) was calculated as first event date minus first randomization date plus 1 divided by 30.4.

Time frame: Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.

Population: FAS included all randomized participants regardless of what treatment, if any, was received.

Protein involved TGFB1, VEGF-A, VEGF-C, PIGF, Endoglin, BMP-9, VEGFR1, VEGFR2, VEGFr3, Ang-2, VEGF-D, CD54, CD106, and CCL2. Tumor molecular characteristics including but not limited to transcriptomic (ribonucleic acid) signatures of efficacy.

Time frame: Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.

Population: FAS included all randomized participants regardless of what treatment, if any, was received.

TTP was defined as the time from first randomization to date of first documentation of objective tumor progression. If tumor progression data included more than (\>) 1 date, the first date was to be used. TTP (in months) was calculated as first event date or last known progression-free date minus the first randomization date plus 1 divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease per Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1).

Time frame: Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.

Population: FAS included all randomized participants regardless of what treatment, if any, was received.

Time frame: 0 hour (predose) on Day 1 of Cycles 1, 2, 4, 6, and 8

Population: The PK concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.