The HCC trial landscape in 2026
Hepatocellular carcinoma is one of the most commercially competitive solid tumor settings. The atezolizumab plus bevacizumab approval (IMbrave150) reset the first-line standard of care, triggering a wave of combination immunotherapy trials that continues to mature. Durvalumab plus tremelimumab (HIMALAYA) added a second approved first-line regimen. Now, the competitive focus has shifted to second-line options after IO failure, adjuvant settings following resection or ablation, and novel mechanisms including anti-TIGIT, anti-LAG-3, and the emerging class of liver-targeted ADCs.
For oncology BD, medical affairs, and investment professionals, the HCC pipeline requires continuous monitoring. New Phase 2 data emerges monthly, Phase 3 readouts drive valuation events, and early Phase 1 entries signal which mechanisms are attracting capital and development resources.
Key HCC program categories to monitor:
- First-line combinations: IO + anti-VEGF combinations competing with atezolizumab/bevacizumab and durvalumab/tremelimumab
- Second-line after IO failure: Regorafenib, cabozantinib, and novel agents for patients who progressed on first-line IO
- Adjuvant/perioperative: Atezolizumab, nivolumab, and next-generation IO in resected or ablated early HCC
- Novel checkpoints: Anti-TIGIT (tiragolumab), anti-LAG-3, anti-TIM-3, and CTLA-4/PD-1 bispecifics
- Liver-targeted ADCs: Programs exploiting GPC3, AFP, CLDN6, and other HCC-enriched antigens
- Locoregional combination: Systemic IO plus TACE/TARE in intermediate-stage HCC
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Configure your profile with keywords as specific or broad as your intelligence needs require. Examples:
- By line/setting: "advanced HCC", "unresectable hepatocellular carcinoma", "adjuvant HCC", "resectable liver cancer"
- By mechanism: "PD-L1 hepatocellular", "VEGF liver cancer", "GPC3 HCC", "TIGIT hepatocellular"
- By agent class: "TKI HCC", "immunotherapy liver cancer", "antibody-drug conjugate hepatocellular"
- Phase filter: Phase 3 for competitive intelligence, all phases for complete pipeline visibility
- By sponsor: Track AstraZeneca, Roche/Genentech, Bristol Myers Squibb, Merck, or smaller innovators in the ADC and targeted space
What DataLookout adds to ClinicalTrials.gov
ClinicalTrials.gov RSS feeds tell you that a study record was updated. DataLookout compares each record against the previous day across 12 tracked fields and tells you which one changed, with the old and new values, for every Hepatocellular Carcinoma trial on your watchlist. Each change is classified as critical, notable, or minor, so a completion date pushed out by two years does not read the same as a contact-details edit.
Who uses HCC trial monitoring
Oncology business development teams
Companies with liver cancer franchises or developing IO combinations monitor HCC trial activity continuously. With AstraZeneca, Roche, BMS, Merck, and Gilead all active in the HCC IO space, understanding the competitive Phase 3 landscape is essential for licensing and co-development decisions. The locoregional combination space (IO plus TACE/TARE) is particularly active, with multiple sponsors vying to establish the standard of care for intermediate-stage HCC.
Healthcare fund analysts
Analysts covering oncology use HCC trial registrations as leading indicators for companies with liver cancer programs. A Phase 3 start for a GPC3-targeting ADC or an adjuvant Phase 3 IO trial can precede significant valuation events. Daily monitoring ensures no registration is missed before it becomes investor news.
Medical affairs and clinical development professionals
Medical affairs teams at HCC-focused companies track competitor trials to anticipate label changes, prepare for new entrants, and inform key opinion leader strategy. In a field where the treatment algorithm continues to evolve from one approved regimen to multiple competing options, real-time competitive awareness is essential.
Current HCC trial activity (as of early 2026)
Based on ClinicalTrials.gov data updated daily by DataLookout:
| Phase | Recruiting Trials | Key Sponsors |
|---|---|---|
| Phase 3 | 37 | AstraZeneca, Roche, BMS, Merck, Gilead |
| Phase 2 | 128 | Akeso, Innovent, Zymeworks, NCI, academic centers |
| Phase 1 / Phase 1–2 | ~50 | NCI, emerging biotechs, ADC developers |
| Total recruiting | 156 | ~80 industry-sponsored |
The first-line IO combination space is consolidating. AstraZeneca has multiple Phase 3 trials running in HCC including studies combining durvalumab with novel agents beyond tremelimumab. Roche's TIGIT inhibitor tiragolumab is being tested in combination with atezolizumab plus bevacizumab in earlier-line settings. Gilead's magrolimab (anti-CD47) has an HCC program after its success in hematologic malignancies.
The ADC wave is arriving in HCC. GPC3 — highly expressed on hepatocellular carcinoma cells — is the primary target, with multiple GPC3-targeting ADCs from Chinese and Western biotechs entering Phase 1 and early Phase 2. Akeso's bispecific PD-1/VEGF antibodies have generated compelling Phase 2 data, driving multiple Phase 3 initiations in the HCC setting.
The adjuvant HCC space is particularly active following the phase 3 data supporting adjuvant atezolizumab. Multiple programs are studying adjuvant IO combinations in patients who have undergone surgical resection, ablation, or locoregional therapy — a setting with fewer treatment options and lower competition than advanced HCC.
Frequently asked questions
1203 active trials, 678 recruiting. Phases: Early Phase 1: 18, Phase 1: 222, Phase 2: 405, Phase 3: 92, Phase 4: 26.
| Top sponsor | Trials |
|---|---|
| AstraZeneca | 18 |
| Roche / Genentech | 8 |
| Akeso | 6 |
| AbbVie | 5 |
| Suzhou Suncadia Biopharmaceuticals Co., Ltd. | 4 |
| Trial | Status | Latest tracked change | Seen |
|---|---|---|---|
| GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable… NCT07209813 | Recruiting | Completion pushed: 2026-10-31 → 2027-10-31 | 2026-08-18 |
| Shuganhuazhuo Formula for Advanced Hepatocellular Carcinoma With Damp-Heat… NCT07691645 | Not Yet Recruiting | Completion pushed: 2031-08-31 → 2032-08-31 | 2026-08-28 |
| Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers… NCT07781852 | Not Yet Recruiting | Primary endpoint(s) modified | 2026-08-26 |
| Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma… NCT05517811 | Recruiting | Enrollment reduced: 400 → 200 participants | 2026-08-25 |
| A First-in-Human Study of HH160 in Participants With Advanced or Metastatic… NCT07623369 | Recruiting | Primary completion moved earlier: 2028-08 → 2027-08 | 2026-08-22 |
Each trial page shows every change DataLookout has recorded for that trial.
DataLookout checks ClinicalTrials.gov every day and records what changed on each trial: status, enrollment, phase, primary endpoint, completion dates, sites, sponsor, and the stated reason a trial stopped. Add a sponsor or a disease to your watchlist, or save any search, and the changes arrive in a daily or weekly email digest.
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