HCC - Hepatocellular CarcinomaSWITCHNCT07410715
Surgery vs. Watch-and-Wait Strategy in Partial & Complete Responders for Hepatocellular Carcinoma
An observational study of HCC - Hepatocellular Carcinoma and Watch & Wait, run by West China Hospital at 1 site in China.
Trial summary
The "Surgery versus Maintenance after Conversion-therapy-achieved Complete/Partial Response in Hepatocellular Carcinoma (SWITCH)" study is a multicenter, open-label, prospective non-randomized cohort study with the protocol number SWITCH-01 (Version 0.1, dated October 5, 2025). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Watch & Wait, Surgery
- What is being tested?
- Surgical Resection and Maintenance Therapy Group
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatocellular carcinoma (HCC) who achieve complete response (CR) or partial response (PR) following conversion therapy and are deemed eligible for radical hepatectomy (R0 resection) by the multidisciplinary team (MDT) at participating centers.
Who may be able to join
- Aged 18-80 years.
- Diagnosed with locally advanced, metastatic, and/or initially unresectable hepatocellular carcinoma (uHCC) via histology/cytology or clinical criteria (AASLD standards for cirrhotic patients; histopathological confirmation required for non-cirrhotic patients).
- Previously judged unresectable or inappropriate for resection by MDT during initial diagnosis or disease course, with at least one evaluable lesion per RECIST v1.1.
- Completed conversion therapy [systemic therapy (PD-1/PD-L1 ± TKI) ± local therapy (TACE/HAIC/radiation/ablation, etc.)], achieved CR or PR (primarily assessed by mRECIST, with concurrent RECIST v1.1 documentation), and confirmed via re-evaluation with the same imaging modality ≥4 weeks later.
- Meets necessary conditions for resection: Child-Pugh Class A liver function, ICG R15 <30%, and future liver remnant (FLR) accounting for ≥40% of standard liver volume (SLV) in patients with chronic liver disease, hepatic parenchymal injury, or cirrhosis, or ≥30% in patients without liver fibrosis or cirrhosis.
- For patients with previous portal vein/hepatic vein/inferior vena cava tumor thrombus (without atrial tumor thrombus), enrollment is permitted only if the thrombus has significantly regressed after conversion therapy, MDT confirms feasibility of R0 resection, and risks are acceptable.
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- ECOG performance status 0-1.
- Adequate organ and bone marrow function, as evidenced by: hemoglobin ≥90g/L; absolute neutrophil count ≥1.5×10⁹/L; platelets ≥60×10⁹/L; total bilirubin ≤1.5×upper limit of normal (ULN); AST, ALT, and ALP ≤2.5×ULN; serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥50ml/min (Cockcroft-Gault formula); urine protein <(++) or 24-hour urine protein <1.0g.
- Normal coagulation function without active bleeding: INR ≤1.5×ULN; APTT ≤1.5×ULN.
- For patients with active hepatitis B virus (HBV) infection: those already receiving anti-HBV therapy (per local standard treatment) must agree to continue during the study; those not receiving anti-HBV therapy must initiate treatment (per local standard treatment) during screening and agree to continue throughout the study.
- For patients with HCV infection: excluded if HCV RNA is detectable.
- No pregnancy or pregnancy plans: fertile females must have a negative urine/serum pregnancy test within 7 days before first dosing and agree to use effective contraception during the study and for 120 days after last dosing; non-sterilized males must agree to use effective contraception during the study and for 120 days after last dosing.
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC.
- Extrahepatic metastasis confirmed by chest, abdominal, and pelvic CT and/or MRI.
- Inability to achieve R0 resection.
- Previous liver transplantation or on the liver transplantation waiting list.
- Decompensated cirrhosis (persistent or refractory ascites, hepatic encephalopathy, progressive jaundice, etc.); Child-Pugh Class B with score ≥8 or Class C; ALBI Grade 3.
- Significant and uncontrollable portal hypertension (e.g., markedly elevated HVPG with recurrent variceal bleeding, refractory ascites).
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- Active gastrointestinal bleeding within the past 4 weeks or uncorrectable coagulation disorders.
- Active infection/sepsis or unresolved Grade ≥2 immune-related adverse events (irAEs).
- Severe cardiopulmonary/renal insufficiency (e.g., NYHA Class III-IV, recent myocardial infarction/stroke, dialysis dependency).
- Pregnancy or lactation.
- Other active malignant tumors within the past 5 years (exceptions for low-risk tumors such as basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- Inability to undergo standardized imaging assessments (multiphase contrast-enhanced CT/MRI) or poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Kunlin Xie, MD, 8618980607259, xiekun@scu.edu.cn
About this study
Official title: Surgery Versus Maintenance After Conversion-therapy-Achieved Complete/Partial Response in Hepatocellular Carcinoma: a Prospective Multicenter Non-randomized Cohort Study
The "Surgery versus Maintenance after Conversion-therapy-achieved Complete/Partial Response in Hepatocellular Carcinoma (SWITCH)" study is a multicenter, open-label, prospective non-randomized cohort study with the protocol number SWITCH-01 (Version 0.1, dated October 5, 2025). Sponsored by West China Hospital of Sichuan University and led by Principal Investigator Wu Hong, the study involves 10 participating centers and has completed NCT registration. Its core objective is to evaluate and compare the efficacy and safety of two management strategies-surgical resection and maintenance therapy-in patients with hepatocellular carcinoma (HCC) who have achieved complete response (CR) or partial response (PR) after conversion therapy and are deemed eligible for curative liver resection (R0) by a multidisciplinary team (MDT). The study is designed to address the clinical dilemma of optimal management for initially unresectable HCC patients who attain favorable responses to conversion therapy, providing high-level evidence for clinical decision-making.
- Conditions
- HCC - Hepatocellular Carcinoma, Watch & Wait, Surgery
- Being tested
- Surgical Resection, Maintenance Therapy Group
- Keywords
- HCC, watch and wait, surgery
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ResectionOther
Patients in the Surgical Resection (SR) cohort should undergo curative resection within 1-2 weeks after the index date. Perioperative medication management shall be conducted in accordance with the participating center's standards, and unified pathological assessments shall be performed for pathological complete response (pCR), major pathological response (MPR), and surgical margin status. Adjuvant therapy shall be initiated 4-8 weeks postoperatively, using the same preoperative PD-1/PD-L1 inhibitor ± tyrosine kinase inhibitor (TKI) regimen, and continued until the occurrence of radiological progression, death, or fulfillment of the drug discontinuation criteria.
[The index date is defined as the first date on which the Multidisciplinary Team (MDT) simultaneously confirms that "complete response (CR)/partial response (PR) has been achieved and surgical resection is feasible," and it serves as the common time zero for both cohorts.]
Maintenance Therapy GroupOther
Patients in the Maintenance Therapy (MT) cohort shall continue treatment with PD-1/PD-L1 inhibitor ± tyrosine kinase inhibitor (TKI) starting from the index date, until the occurrence of radiological progression, death, or fulfillment of the drug discontinuation criteria.
[The index date is defined as the first date on which the Multidisciplinary Team (MDT) simultaneously confirms that "complete response (CR)/partial response (PR) has been achieved and surgical resection is feasible," and it serves as the common time zero for both cohorts.]
| Study group | Role | What they receive |
|---|---|---|
| Surgical Resection (SR) cohort | Not described Receives: Other: Surgical Resection | |
| Maintenance Therapy (MT) cohort | Not described Receives: Other: Maintenance Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Failure (TTF) per RECIST v1.1
TTF is defined as the time from the date of enrollment to the date of first documented treatment failure, including local recurrence, intrahepatic progression, extrahepatic spread (EHS), or death from any cause. Tumor assessment is performed using CT or MRI evaluated by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From date of enrollment until treatment failure, assessed up to 36 months
Secondary outcomes (5)
Time to Treatment Failure (TTF) per mRECIST
TTF assessed by IRF and investigators according to modified RECIST (mRECIST) for Hepatocellular Carcinoma. Defined as time from date of enrollment to treatment failure (recurrence, progression, or death).
Measured: From date of enrollment until treatment failure, assessed up to 36 months
Overall Survival (OS)
OS is defined as the time from the date of enrollment to the date of death due to any cause. For patients still alive at the time of analysis, the data will be censored at the last date the patient was known to be alive.
Measured: From date of enrollment until death, assessed up to 36 months
12-month Overall Survival (OS) Rate
The proportion of participants who are alive at 12 months after the date of enrollment.
Measured: At 12 months post-enrollment
Pattern of Recurrence or Progression
Characterization of the first failure event classified by site: Intrahepatic (local recurrence vs. new lesion) or Extrahepatic (distant metastasis). Confirmation involves radiographic evaluation (CT/MRI) and, where feasible, histological/cytological confirmation. Categorized as solitary vs. multiple lesions and resectable vs. unresectable.
Measured: From date of enrollment until first recurrence/progression, assessed up to 36 months
Incidence of Adverse Events (AEs)
Percentage of participants experiencing treatment-emergent adverse events. AEs are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for systemic therapy, and surgical complications are graded according to the Clavien-Dindo Classification and comprehensive complication index (CCI).
Measured: From date of enrollment through 90 days after the last dose of study treatment or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunlin Xie, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410715
- Sponsor's protocol ID
- 2025-2584
- Acronym
- SWITCH
- Status last verified
- Sep 2026
- First submitted
- 29 Dec 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus Maintenance After Conversion-therapy-Achieved Complete/Partial Response in Hepatocellular Carcinoma: a Prospective Multicenter Non-randomized Cohort Study
- ClinicalTrials.gov ID
- NCT07410715
- Acronym / sponsor ID
- SWITCH / 2025-2584
- Conditions
- HCC - Hepatocellular Carcinoma, Watch & Wait, Surgery
- Keywords
- HCC, watch and wait, surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The "Surgery versus Maintenance after Conversion-therapy-achieved Complete/Partial Response in Hepatocellular Carcinoma (SWITCH)" study is a multicenter, open-label, prospective non-randomized cohort study with the protocol number SWITCH-01 (Version 0.1, dated October 5, 2025). Sponsored by West China Hospital of Sichuan University and led by Principal Investigator Wu Hong, the study involves 10 participating centers and has completed NCT registration. Its core objective is to evaluate and compare the efficacy and safety of two management strategies-surgical resection and maintenance therapy-in patients with hepatocellular carcinoma (HCC) who have achieved complete response (CR) or partial response (PR) after conversion therapy and are deemed eligible for curative liver resection (R0) by a multidisciplinary team (MDT). The study is designed to address the clinical dilemma of optimal management for initially unresectable HCC patients who attain favorable responses to conversion therapy, providing high-level evidence for clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Resection (SR) cohort | – | Other: Surgical Resection |
| Maintenance Therapy (MT) cohort | – | Other: Maintenance Therapy Group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma (HCC) who achieve complete response (CR) or partial response (PR) following conversion therapy and are deemed eligible for radical hepatectomy (R0 resection) by the multidisciplinary team (MDT) at participating centers.
Key inclusion criteria (12 listed)
- Aged 18-80 years.
- Diagnosed with locally advanced, metastatic, and/or initially unresectable hepatocellular carcinoma (uHCC) via histology/cytology or clinical criteria (AASLD standards for cirrhotic patients; histopathological confirmation required for non-cirrhotic patients).
- Previously judged unresectable or inappropriate for resection by MDT during initial diagnosis or disease course, with at least one evaluable lesion per RECIST v1.1.
- Completed conversion therapy [systemic therapy (PD-1/PD-L1 ± TKI) ± local therapy (TACE/HAIC/radiation/ablation, etc.)], achieved CR or PR (primarily assessed by mRECIST, with concurrent RECIST v1.1 documentation), and confirmed via re-evaluation with the same imaging modality ≥4 weeks later.
- Meets necessary conditions for resection: Child-Pugh Class A liver function, ICG R15 <30%, and future liver remnant (FLR) accounting for ≥40% of standard liver volume (SLV) in patients with chronic liver disease, hepatic parenchymal injury, or cirrhosis, or ≥30% in patients without liver fibrosis or cirrhosis.
Key exclusion criteria (12 listed)
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC.
- Extrahepatic metastasis confirmed by chest, abdominal, and pelvic CT and/or MRI.
- Inability to achieve R0 resection.
- Previous liver transplantation or on the liver transplantation waiting list.
- Decompensated cirrhosis (persistent or refractory ascites, hepatic encephalopathy, progressive jaundice, etc.); Child-Pugh Class B with score ≥8 or Class C; ALBI Grade 3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical ResectionPatients in the Surgical Resection (SR) cohort should undergo curative resection within 1-2 weeks after the index date. Perioperative medication management shall be conducted in accordance with the participating center's standards, and unified pathological assessments shall be performed for pathological complete response (pCR), major pathological response (MPR), and surgical margin status. Adjuvant therapy shall be initiated 4-8 weeks postoperatively, using the same preoperative PD-1/PD-L1 inhibitor ± tyrosine kinase inhibitor (TKI) regimen, and continued until the occurrence of radiological progression, death, or fulfillment of the drug discontinuation criteria. [The index date is defined as the first date on which the Multidisciplinary Team (MDT) simultaneously confirms that "complete response (CR)/partial response (PR) has been achieved and surgical resection is feasible," and it serves as the common time zero for both cohorts.] | Other | Surgical Resection (SR) cohort |
| Maintenance Therapy GroupPatients in the Maintenance Therapy (MT) cohort shall continue treatment with PD-1/PD-L1 inhibitor ± tyrosine kinase inhibitor (TKI) starting from the index date, until the occurrence of radiological progression, death, or fulfillment of the drug discontinuation criteria. [The index date is defined as the first date on which the Multidisciplinary Team (MDT) simultaneously confirms that "complete response (CR)/partial response (PR) has been achieved and surgical resection is feasible," and it serves as the common time zero for both cohorts.] | Other | Maintenance Therapy (MT) cohort |
Primary outcome
Time to Treatment Failure (TTF) per RECIST v1.1
Time frame: From date of enrollment until treatment failure, assessed up to 36 months
TTF is defined as the time from the date of enrollment to the date of first documented treatment failure, including local recurrence, intrahepatic progression, extrahepatic spread (EHS), or death from any cause. Tumor assessment is performed using CT or MRI evaluated by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
5 secondary outcomes
Time to Treatment Failure (TTF) per mRECIST
Time frame: From date of enrollment until treatment failure, assessed up to 36 months
Overall Survival (OS)
Time frame: From date of enrollment until death, assessed up to 36 months
12-month Overall Survival (OS) Rate
Time frame: At 12 months post-enrollment
Pattern of Recurrence or Progression
Time frame: From date of enrollment until first recurrence/progression, assessed up to 36 months
Incidence of Adverse Events (AEs)
Time frame: From date of enrollment through 90 days after the last dose of study treatment or surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC - Hepatocellular Carcinoma and Watch & Wait, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kunlin Xie, MD/PhD (+86 18980607259, xiekun@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Failure (TTF) per RECIST v1.1 (time frame: From date of enrollment until treatment failure, assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.