Clinical trial NCT04888546: 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
Official title: A Single-arm, Multicenter Phase Ib Clinical Trial of the Efficacy and Safety of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Neoadjuvant in the Treatment of Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Patients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or Metastasi
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2021-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Criteria:

1. Voluntary participation and written informed consent;
2. Age: 18-75 years old;ECOG PS：0-1；The expected survival is more than 6 months;
3. No gender limitation;
4. Histologically confirmed hepatocellular carcinoma;
5. Meet resectable surgical criteria;
6. Child-Pugh:A or B;
7. According to RECIST 1.1, there is at least one evaluable lesion that has not been treated;

Exclusion Criteria:

1. Fibrolamellar HCC, sarcomatoid HCC, or mixed bile duct cell-HCC is known to exis;
2. Preoperative systemic treatment including chemotherapy, targeted therapy and immunotherapy;Preoperative local treatment including radiotherapy, interventional therapy and ablative therapy;
3. No radical resection could be performed after adequate imaging evaluation;
4. 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;

Primary outcomes:
measure: Pathological complete response rate (pCR)
timeFrame: 6 months
measure: Overall response rate (ORR)
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Progression free survival(PFS)
timeFrame: through study completion, an average of 1 year
measure: Overall survival (OS)
timeFrame: through study completion, an average of 1 year
measure: The incidence and severity of AE
timeFrame: through study completion, an average of 1 year
measure: The incidence and severity of SAE
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: