Neoadjuvant Therapy of HAIC(GEMOX) Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors:NEO-ERA-01 Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Clinical Study on the efficacy and safety of HAIC(GEMOX)and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• The patient must sign the informed consent;

• Age 18-75 years old, male and female;

• ECOG Physical status Score (PS score) 0 or 1;

• Patients with ICC who have been pathologically diagnosed (histopathological and/or cytological examination) or clinically diagnosed as having high-risk factors;

• Risk factors are defined as follows:

• Stage ≥Ib, single lesion \> 5cm, multiple tumor lesions in the same lobe, technically resectable;Vascular invasion, regional lymph node metastasis, technically resectable

• Patients with untreated and resectable locally advanced ICC who have been assessed by the surgeon as surgically resectable;

• The functional indicators of vital organs meet the following requirements

• ① Neutrophils ≥1.5\*109/L; Platelet ≥80\*109/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl;② Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal, T3, T4 in the normal range;③ Bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal value;④ Serum creatinine ≤ 1.5 times the upper limit of normal value, creatinine clearance ≥60 ml/min;

• The subject has at least one measurable lesion (according to RECIST1.1);

• Fertile women: must agree to abstain from sex (abstain from heterosexual intercourse) or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Serum HCG test must be negative within 72 hours before randomization. And must be non-lactating.A woman is considered fertile if she has menstruated, has not yet reached postmenopausal status (no continuous periods for ≥12 months, no cause other than menopause has been found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

• For male subjects whose partner is a fertile woman, they must agree to abstain from sex or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Male subjects also had to agree not to donate sperm during the same time period. Male subjects with a pregnant partner are required to use condoms and do not need to use other methods of contraception.

Locations
Other Locations
China
West China Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
Contact Information
Primary
Feng Cheng, MD
docchengfeng@njmu.edu.cn
13305170695
Backup
Jianhua Rao, MD
raojh@njmu.edu.cn
18262637266
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2027-01
Participants
Target number of participants: 33
Treatments
Experimental: Combined treatment group
1. Preoperative treatment 3 weeks is a course of treatment HAIC (GEMOX) chemotherapy~ 1. It is performed within one week after the identification of ICC~ 2. Day 1 HAIC (GEMOX) Oxaliplatin 85mg/m2 + Gemcitabine 800mg/m2 Adebrelimab: Day 3 Adebrelimab 1200mg i.v. Lenvatinib 2# qd~2. Evaluation every 2 courses, up to 4 courses.~3. Liver resection: It is performed within 1 month after preoperative treatment.~4. Postoperative treatment: Day 1-14 Capecitabine 1200mg B.I.D.
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov