An observational study in Hepatocellular Carcinoma, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Shanghai Zhongshan Hospital · Observational
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Among 63 studies in Carcinoma, Hepatocellular by Shanghai Zhongshan Hospital — 26 open to participants now, 30 under way, 3 of them phase 3. Carcinoma, Hepatocellular · Shanghai Zhongshan Hospital.
Among the 63 studies in Carcinoma, Hepatocellular by Shanghai Zhongshan Hospital, this one is the 7th largest by planned enrollment of the 21 observational ones that give a count, is one of 9 that started in 2026, is one of 21 observational ones, reaches primary completion later than 18 of the 29 other live ones, and was the 62nd registered.
3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.
Browse Carcinoma, Hepatocellular studies →26 of the 63 studies in Carcinoma, Hepatocellular by Shanghai Zhongshan Hospital are open now, in 1 country. Recruiting first, the newest first:
Shanghai Zhongshan Hospital · Sites in China
Ages 18–80
Shanghai Zhongshan Hospital · Sites in China
Ages 18–80
Shanghai Zhongshan Hospital · Sites in China
Ages 18–75
Shanghai Zhongshan Hospital · Sites in China
Ages 18–90
Shanghai Zhongshan Hospital · Sites in China
By country, each count listing its studies:
Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
63 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 25 · Phase 3 9
First in 2014; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 200 across 851 observational studies indexed under Carcinoma, Hepatocellular.
Median enrollment 44 across the 42 interventional studies, 300 across the 21 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
4 of the studies in Carcinoma, Hepatocellular by Shanghai Zhongshan Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07786792Shanghai Zhongshan HospitalBiomarker and Mechanism Study of Systemic Therapy in Unresectable HCC | 2027-01-01 |
| NCT07919717Shanghai Zhongshan HospitalNIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC | 2027-05-12 |
| NCT07781176Shanghai Zhongshan HospitalDifferent Acupoint Stimulation for Postoperative Gastrointestinal Dysfunction in Primary Liver Cancer Patients | 2027-07-31 |
| NCT07714317Shanghai Zhongshan HospitalPhase Ib/II Multicenter Randomized Control Study of Peri-operative Treatment With Combination of CTLA-4, PD-1 Antibodies and Bevacizumab in Resectable HCC (Prophet) | 2027-07-31 |
Add all 4 to your calendar (.ics) → With an account.
Among the 63 studies in Carcinoma, Hepatocellular by Shanghai Zhongshan Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this observational study is to evaluate the safety and efficacy of systemic therapies and identify predictive molecular biomarkers in patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC).
The main questions it aims to answer are:What is the objective response rate (ORR) of systemic therapy regimens in this patient population? Which 3-4 specific biomarkers (including tumor or peripheral blood-derived genes, proteins, ctDNA, and immune cell subsets) can reliably predict the efficacy of systemic treatment?
The study population consists of patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC) confirmed by histology, cytology, or clinical diagnostic criteria. Eligible patients must have an ECOG performance status of 0 to 2 and well-preserved liver function, defined as Child-Pugh class A or a score of 7. The population includes patients who are scheduled to receive standard systemic therapies, such as targeted therapy combined with immunotherapy or dual immunotherapy, either alone or in combination with local therapies like transcatheter arterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC) receiving systemic therapy alone.
Drug: Systemic therapy
Patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC) receiving transcatheter arterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with systemic therapy.
Drug: Systemic therapy · Procedure: Local therapy
Including regimens such as Atezolizumab + Bevacizumab, Nivolumab + Ipilimumab.
Including therapy such as TACE, HAIC
This study also gives Nivolumab, Ipilimumab, Atezolizumab. No intervention listed here names it: that was found by reading the record.
Objective Response Rate (ORR) Assessed by RECIST v1.1 and HCC mRECIST Criteria
The ORR will be evaluated according to RECIST v1.1 and HCC mRECIST criteria, defined as the sum of complete response (CR) and partial response (PR) in patients with at least one measurable lesion.defined as the sum of complete response (CR) and partial response (PR) in patients with at least one measurable lesion.
Time frame: Up to 2 years (assessed every 8 ± 2 weeks)
Levels of Predictive Biomarkers Assessed by Multi-Omics Sequencing and Single Cell RNA Sequencing
Identify 3-4 predictive biomarkers for the efficacy of HCC systemic therapy, including genes, proteins, ctDNA, and immune cell subsets based on tumor tissue or peripheral blood.
Time frame: Up to 2 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2027, 4 months later.
Of 303 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 114. This study's planned 4 months is below that.
Counting every sponsor, half of 352 studies reached it within 51 months; a quarter within 32 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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