Comparing two treatment methods for advanced liver cancer
Official title: Infusional FOLFOX Plus Camrelizumab and Apatinib Versus HAIC-FOLFOX Plus Camrelizumab and Apatinib for Hepatocellular Carcinoma of BCLC C Stage: A Multi-center Randomized Phase III Trial
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06172205 · Data updated 2026-11-12
This study is testing two different treatment methods for advanced liver cancer to see which one helps patients feel better and live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 262 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Camrelizumab, apatinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | July 1, 2023 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2029 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT06172205 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with BCLC Stage C hepatocellular carcinoma who have not received prior first-line treatments.
✕Probably not a fit
Patients with Child-Pugh grade C liver function or those who have previously received first-line therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III clinical trial is a multi-center, randomized study that evaluates the effectiveness of intravenous FOLFOX combined with Camrelizumab and Apatinib against HAIC-FOLFOX combined with the same drugs for patients with BCLC Stage C hepatocellular carcinoma. Participants will be assigned to one of the two treatment groups to assess which approach yields better outcomes. The study aims to determine the optimal first-line treatment for this advanced stage of liver cancer.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced hepatocellular carcinoma.
How similar studies have gone: Other studies have shown promising results with similar treatment combinations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-75, male or female; 2. The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to BCLC stage C. 3. Child-pugh liver function grading: Grade A or B 4. Did not received any type of other first-line drugs such as Sorafenib 5. According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments); 6. ECOG PS score 0-2; 7. Expected survival ≥ 12 weeks; 8. The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days): Blood routine:White blood cells count ≥3.0×10\^9/L Platelet count ≥70×10\^9/L Hemoglobin ≥80g/L(without blood transfusion); Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN) 9. Subjects with HBV or HCV infection should receive anti-virus treatment without interfron. 10. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication;Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period. 11. Patients volunteered to participate in this study and signed informed consent; Subjects have good compliance and cooperate with the follow-up. Exclusion Criteria: 1. Have received immunotherapeutic drugs or interferon in the past. 2. Severe allergic reaction to other monoclonal antibodies, immunotherapy or chemotherapy. 3. Female subjects with pregnancy or on feeding. 4. Patients with congenital or acquired immune deficiencies. 5. Abnormal coagulation function (INR\>2.0, PT\>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin 6. The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ) 7. The patient has active infection, fever of unknown origin within 7 days (CTCAE\>2) 8. Patients with congenital or acquired immune deficiencies. 9. Severe coagulation dysfunction (INR \> 2.0, PT \> 16s), with a significant tendency to bleed (including but not limited to vomiting blood or passing blood in stool daily within the past 3 months); 10. Moderate to severe ascites with clinical symptoms that require therapeutic puncture or drainage, or Child-Pugh score \> 2 (except for cases where imaging shows only a small amount of ascites without clinical symptoms); uncontrolled or moderate to large pleural effusion or pericardial effusion; 11. Patients are to be excluded if they have a history of gastrointestinal bleeding within 6 months prior to the start of the study treatment, or have a definite tendency for gastrointestinal bleeding, including but not limited to: bleeding-risk or severe esophageal/gastric varices, locally active ulcerative lesions, or persistently positive fecal occult blood tests. 12. Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment; 13. Occurrence of thrombotic or embolic events within 6 months prior to the start of study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, cerebrovascular abnormalities, cerebral aneurysm), pulmonary embolism, etc.; 14. Major vascular disease within 6 months prior to the start of study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis); severe, unhealed, or dehisced wounds, as well as active ulcers or untreated fractures; Criteria for Discontinuation of Study Treatment 15. Previous or current presence of central nervous system metastases; 16. Individuals with a history of substance abuse of psychiatric medications who are unable to quit, or those with mental disorders; or those with brain metastases or hepatic encephalopathy; 17. According to the judgment of the investigator, the patients with factors that may affect the results of the study or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients
Where it's running
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Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Yunxiuxiu Xu, MD
- Email: xuyxx@mail.sysu.edu.cn
- Phone: 17722864609
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Camrelizumab plus apatinib with or without FOLFOX chemotherapy for advanced liver cancer
This research will test whether adding FOLFOX chemotherapy to camrelizumab plus apatinib helps adults with advanced hepatocellular carcinoma who have not received prior systemic treatment.
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VRT106 plus camrelizumab and apatinib for advanced HCC in patients who have tried prior ICIs
This study tests VRT106, with camrelizumab and apatinib, to see if it helps people with advanced hepatocellular carcinoma who have already had prior immune checkpoint inhibitors fail.
-
Y-90 microspheres with camrelizumab and/or apatinib versus Y-90 alone or cTACE for unresectable liver cancer
This trial will test whether adding camrelizumab and/or apatinib to Y-90 microsphere treatment helps people with unresectable, non-metastatic hepatocellular carcinoma more than Y-90 alone or conventional TACE.
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Apatinib and camrelizumab plus TACE before liver resection for centrally-located BCLC‑B hepatocellular carcinoma
This trial tests whether giving apatinib and camrelizumab together with TACE before planned liver surgery can shrink tumors and improve outcomes for adults with centrally-located BCLC stage B hepatocellular carcinoma who are eligible for resection.
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Perioperative radiotherapy with SOX chemotherapy plus apatinib and camrelizumab for esophagogastric cancer
This trial tests whether adding apatinib and camrelizumab to SOX chemotherapy and radiotherapy before and after surgery helps adults with locally advanced gastric or GEJ adenocarcinoma.
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Camrelizumab plus apatinib and eribulin versus physician's choice chemotherapy for advanced triple-negative breast cancer
This trial tests whether combining camrelizumab, apatinib, and eribulin works better than your doctor's chosen chemotherapy for adults with advanced triple-negative breast cancer who have had 1–4 prior systemic treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.