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A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma (HCC)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing Sanhome Pharmaceutical, Co., Ltd.

About this trial

To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects participate voluntarily and sign informed consent.

Age ≥ 18 and ≤ 75 years old, male or female.

Histological or clinical diagnosis of HCC.

Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment

Disqualifiers

Histologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, etc.

History of malignancy other than HCC within 5 years prior to the start of study treatment.

History of liver transplantation, or planned to receive liver transplantation.

Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SH006

    Drug

    15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

  • Bevacizumab

    Drug

    15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

  • Oxaliplatin injection

    Drug

    85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle

  • Capecitabine

    Drug

    1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle

  • Regorafenib

    Drug

    160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Arm 1 SH006 in combination with bevacizumab and chemotherapyExperimental treatment 4 interventions
Group B: Arm 2 SH006 in combination with bevacizumabExperimental treatment 2 interventions
Group C: Arm 3 SH006 in combination with chemotherapyExperimental treatment 3 interventions
Group D: Arm 4 RegorafenibActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS) (Phase II)

PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Time frame
Up to approximately 4 years
2

Incidence of Adverse Events (AEs) (Phase II)

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.

Time frame
Up to approximately 4 years
3

Overall Survival (OS) (Phase III)

OS was defined as the time from randomization to death due to any cause.

Time frame
Up to approximately 4 years

Secondary outcomes

1

Objective Response Rate (ORR)

ORR was assessed by investigators per RECIST 1.1

Time frame
Up to approximately 4 years
2

Disease Control Rate (DCR)

DCR was assessed by investigators per RECIST 1.1

Time frame
Up to approximately 4 years
3

Duration of Response (DOR)

DOR was assessed by investigators per RECIST 1.1

Time frame
Up to approximately 4 years
4

Time to progression (TTP)

TTP was assessed by investigators per RECIST 1.1

Time frame
Up to approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Sanhome Pharmaceutical, Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: