Status:
UNKNOWN
TQB2450 Combined With Anlotinib Hydrochloride in the Perioperative Treatment of Hepatocellular Carcinoma Hydrochloride Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Patients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or Metastasi
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
In this study, single cell transcriptome sequencing will be performed on the tissue samples punctured and the surgically resected specimens to explore the gene mutation sites related to efficacy
Eligibility Criteria
Inclusion
- Voluntary participation and written informed consent;
- Age: 18-75 years old;ECOG PS：0-1；The expected survival is more than 6 months;
- No gender limitation;
- Histologically confirmed hepatocellular carcinoma;
- Meet resectable surgical criteria;
- Child-Pugh:A or B;
- According to RECIST 1.1, there is at least one evaluable lesion that has not been treated;
Exclusion
- Fibrolamellar HCC, sarcomatoid HCC, or mixed bile duct cell-HCC is known to exis;
- Preoperative systemic treatment including chemotherapy, targeted therapy and immunotherapy;Preoperative local treatment including radiotherapy, interventional therapy and ablative therapy;
- No radical resection could be performed after adequate imaging evaluation;
- Present or present with other malignant tumors within 3 years.Two conditions were eligible for inclusion: 5 consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation;Cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumor \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\]; 5 . There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- 6\. Hepatitis B combined with hepatitis C; 7. Patients with portal hypertension have high bleeding risk considered by the researcher, or gastroscopy or gastroscopy confirmed red signs, or gastroscopy found active ulcers with high bleeding risk;
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04888546
Start Date
April 30 2021
End Date
July 30 2024
Last Update
May 17 2021
Active Locations (1)
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1
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021