Using 3D-HDRA to guide chemotherapy after liver cancer surgery

Applicability of 3D Histoculture Drug Response Assay(3D-HDRA) in Patients With Primary Liver Cancer: A Randomized Controlled Trial

This study is testing whether using 3D-HDRA results to guide chemotherapy can help people who had surgery for liver cancer stay cancer-free for longer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05701436 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial evaluates the clinical feasibility of using 3D-HDRA results to guide interventional chemotherapy in patients who have undergone surgery for primary liver cancer. Patients who have had a radical resection will receive various chemotherapy agents, and their outcomes will be monitored. The primary endpoint is the one-year disease-free survival rate, while secondary endpoints include the assessment of adverse events. The study aims to clarify the effectiveness of this approach in improving patient outcomes post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of primary liver cancer who have undergone R0 resection.

Not a fit: Patients with recurrent liver cancer or those with existing distant metastases will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance disease-free survival rates for patients with primary liver cancer following surgery.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for cancer patients through tailored chemotherapy regimens.

Eligibility criteria

Inclusion Criteria:

1. Patients voluntarily cooperated with the study and signed an informed consent form.
2. Any gender, age 18 or older, 75 or younger.
3. Patients who need to confirm the maximum tumor load (the maximum diameter of a single tumor lesion) before performing radical surgery; patients with a confirmed diagnosis of primary liver cancer after postoperative pathological histological examination.
4. Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery).
5. Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.
6. ECOG physical fitness status score of 0-1.
7. Women of childbearing age with a negative pregnancy test and willing to use effective contraception for the duration of the study.

Exclusion Criteria:

1. Patients with recurrent liver cancer.
2. Patients with existing extrahepatic distant metastases (including local lymph node metastases or distant organ metastases: e.g., lung, brain, bone, etc.) at the time of diagnosis.
3. Treatment with other experimental drugs or other interventions after radical resection.
4. Patients with other malignant tumors that have not been cured within 5 years.
5. Patients with non-radical resections (R1 and R2 resections).
6. Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery.
7. Patients in whom death occurred within 30 days after surgery.

Where this trial is running

Guangzhou, Guangdong

• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Mingxin Pan, Prof

Conditions Liver, Cancer of, Primary Resectable