A Clinical Study of DEB-TACE Combined With Surufatinib and Camrelizumab in the Treatment of Inoperable or Metastatic ICC

NCT05236699 | Completed Phase 2

• 1 other identifier: HMPL-012-SPRING-B105
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

At present, for advanced Intrahepatic Cholangiocarcinoma（ICC）, the effect of single treatment is not good.So far, superselective drug-eluting bead transarterial chemoembolization（DEB-TACE） is a good method for the treatment of local lesions in advanced ICC.Studies have shown that the combination of sovantinib and immunotherapy has also shown encouraging results, and patients are well tolerated.Therefore, we designed DEB-TACE combined with Surufatinib and Camrelizumab for the exploratory study of inoperable or metastatic ICC, in order to provide a safe, effective and tolerable option for patients with ICC, prolong their survival time and improve their quality of life.

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

DEB-TACE; Surufatinib; Camrelizumab

Outcome Measures

Primary Outcomes (1)

• Objective remission rate (ORR)

  Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR).

  After the first DEB-TACE treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 1 year

Secondary Outcomes (4)

• Progression-free survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

• Disease control rate (DCR)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

• Total Survival time (OS)

  Through study completion, an average of 1 year

• Incidence of adverse events and toxicities of Surufatinib in combination with Camrelizumab

  Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).

Study Arms (1)

DEB-TACE combined with Surufatinib and Camrelizumab

EXPERIMENTAL

Combination Product: DEB-TACE combined with Surufatinib and Camrelizumab

Interventions

DEB-TACE combined with Surufatinib and Camrelizumab COMBINATION_PRODUCT

1. All patients will be treated with standard DEB-TACE on the first day (D1). 2. After DEB-TACE, if the liver function is Child-PughA grade, they will be treated with Camrelizumab on the same day, 200mg/ times, intravenous injection, once every 3 weeks. 3. Surufatinib capsule will be given orally to 250mg within 1 hour after breakfast on the second day (D2) after the first DEB-TACE. The drug will be given continuously once a day and stopped on the same day of each DEB-TACE. 4. The combination of drugs for 3 weeks is a cycle.The treatment will continue until the patient developed the disease or met the other criteria for terminating the study.

DEB-TACE combined with Surufatinib and Camrelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily joined the study and signed an informed consent form with good compliance and follow-up.
• Inoperable or metastatic intrahepatic cholangiocarcinoma diagnosed by histopathology or cytology;
• In accordance with the diagnostic criteria of NCCN guidelines for intrahepatic cholangiocarcinoma, the diagnosis of intrahepatic cholangiocarcinoma that is not suitable for radical resection: unable to obtain R0 resection, multiple liver, lymph node metastasis beyond the hilar area and distant metastasis;
• ECOG score: 0-1; expected survival ≥ 12 weeks;
• Liver function Child-Pugh A grade
• Patients who have not received systematic treatment for unresectable or metastatic biliary tract cancer; those who have received adjuvant or neoadjuvant chemotherapy and relapse 6 months after the end of chemotherapy can be enrolled in the group.
• At least one measurable lesion (according to RECIST1.1 standard); its diameter ≥ 1cm was accurately measured by magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement, and the target lesion had not received local treatment in the past (including not limited to hepatic arterial Infusion chemotherapy, radiofrequency ablation, argon-helium knife, radiotherapy, etc.);
• No serious organic diseases of heart, lung, brain and other organs;
• The functions of major organs and bone marrow are basically normal:
• Blood routine: WBC ≥ 4.0x10\^9/L, neutrophils ≥ 1.5x10\^9/L, platelets ≥ 80x10\^9/L, hemoglobin ≥ 90 g/L
• International standardized ratio (INR) ≤ 1.5 × upper limit of normal value (ULN), and activated partial thromboplastin time (APTT) ≤ 6sbot
• liver function: serum total bilirubin ≤ 2xULN ;ALT/ AST ≤ 2xULN; serum albumin ≥ 28g/L.
• Renal function: serum creatinine ≤ 1.5xULN or eGFR ≥ 60%, and creatinine clearance rate (CCr) 60ml / min; excluding urinary tract infection, urine routine showed that urinary protein \< 2+, 24-hour urine protein should be collected from ≥ 2 + patients \< 1g
• cardiac function was normal, left ventricular ejection fraction (LVEF) ≥ 50% detected by two-dimensional echocardiography.
• Fertile male or female patients voluntarily used effective contraceptive methods during the study period and within 6 months of the last study, such as double barrier contraceptives, condoms, oral or injection contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation).

You may not qualify if:

• Participated in clinical trials of other antineoplastic drugs within 4 weeks before entering the group.
• Received any surgery or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before the start of the group;
• History of hepatectomy, history of TACE treatment, previous immune and targeted therapy;
• gene sequencing identified alterations in FGFR2, such as fusions or rearrangements；
• The researchers determined that liver metastases accounted for 70% or more of the total liver volume;
• Patients who have previously received organ transplants or planned organ transplants;
• Patients with obstructive jaundice but not as expected;
• Suffered from other malignant tumors in the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ;
• Patients who have had any brain metastases or are currently suffering from brain metastases;
• In the first study, he took other strong inducers or inhibitors of CYP3A4 within 2 weeks before medication;
• Received any operation (except biopsy) or invasive treatment or operation within 4 weeks before the start of the group, and the surgical incision did not completely heal (except venous catheterization, puncture and drainage, etc.);
• The researchers judged clinically significant electrolyte abnormalities;
• At present, the patients have hypertension that cannot be controlled by drugs, which is defined as systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg.
• Urine routine showed that the amount of urinary protein was more than 2 grams and the amount of 24-hour urinary protein was more than 1.0 g.
• The researchers determined that during the follow-up study, the tumor was most likely to invade important blood vessels and cause fatal massive bleeding;

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Guo B, Fan Y, Li D, Xia F, Luo C, Zhu J, Wu Y, Zhu Z, Xiang S, Liu E, Zhang W. Locoregional gemcitabine plus surufatinib and camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma. Cell Rep Med. 2025 Dec 16;6(12):102482. doi: 10.1016/j.xcrm.2025.102482. Epub 2025 Dec 4.

  PMID: 41349529 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

surufatinib; camrelizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Wanguang Zhang, M.D.,Ph.D.

  Medical Ethics Committee of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: February 11, 2022
• Study Start: February 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: January 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

CN (1)