Camrelizumab in Combination With Apatinib in Advanced ICC: A Single-arm Phase II Study

NCT ID: NCT04454905

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2025-07-01

Brief Summary

This is a single arm, open-label, non-randomized and single-center phase II clinical study, to evaluate the safety, tolerance, and efficacy of Camrelizumab in combination with Apatinib in patients with advanced intrahepatic cholangiocarcinoma (ICC).

Detailed Description

It is estimated that 50 patients who met the study criteria will be enrolled in 3 years and treated with Camrelizumab plus Apatinib in SYSUCC. The investigators will follow up and collect subjects' data to evaluate the efficacy and safety of treatment, including objective response rate (ORR) and Progression-free Survival (PFS) and Overall Survival (OS), until disease progression or death. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response.

Conditions

Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab combination with Apatinib

Camrelizumab 200mg, every 3 weeks, intravenous infused. Apatinib 250mg, once a day, orally. Until progression or unacceptable toxicity events develop.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

Camrelizumab (Jiangsu HengRui Medicine Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.

Apatinib

Intervention Type: DRUG

Apatinib is a novel angiogenesis inhibitor vascular endothelial growth factor 2.

Interventions

Camrelizumab

Camrelizumab (Jiangsu HengRui Medicine Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.

Intervention Type: DRUG

Apatinib

Apatinib is a novel angiogenesis inhibitor vascular endothelial growth factor 2.

Intervention Type: DRUG

Other Intervention Names

Camrelizumab for Injection; Rivoceranib

Eligibility Criteria

Inclusion Criteria

• Histopathologically confirmed advanced ICC, or combined hepatocellular and cholangiocarcinoma (cHCC-CC, composition of cholangiocarcinoma >50%). nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies.
• Have at least one measurable lesion (in accordance with RECIST v1.1); the measurable lesion has a long diameter ≥ 10 mm or lymphadenopathy has a short diameter ≥ 15 mm in spiral CT scan.
• Child-Pugh Class: Grade A
• ECOG-PS score 0 or 1
• Life Expectancy of at least 3 months
• Have the required screening laboratory values

Exclusion Criteria

• Extrahepatic cholangiocarcinoma (EHCC) and primary liver cancer. other active malignant tumors except for ICC within 3 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled.
• Any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can be controlled with hormone replacement therapy only can be enrolled]); subjects with skin diseases that does no need systemic treatment, for example, leukoderma, psoriasis, alopecia, those with controlled type I diabetes by insulin or those with asthma that has been completely resolved in childhood and with no need of any intervention can be enrolled; while subjects with asthma who need bronchodilator for medical intervention cannot be enrolled;
• Use of strong CYP3A4/CYP2C19 inducers, including rifampicin (and its analogues) and St. John's Wort, or strong CYP3A4/CYP2C19 inhibitors within two weeks prior to signing informed consent form.
• Previous treatment with other immune checkpoint inhibitors (include PD-1 antibody or other immunotherapy against PD-1/PD-L1), or previous use of Apatinib.
• Known history of serious allergy to any monoclonal antibody or Apatinib.
• Inability or unwilling to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption.
• Previous or current presence of metastasis to central nervous system.
• Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within two weeks prior to the start of study treatment (for example, subjects who are given with preventive antibiotics for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study);
• Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Chen Min-Shan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minshan Chen, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Li Xu

Guangzhou, Guangdong, China

Site Status: RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Xu, MD., PhD.

Role: CONTACT

xuli@sysucc.org.cn

+862087343582

Zhishan Lin

Role: CONTACT

linzhsh@sysucc.org.cn

862087343437

Facility Contacts

Li Xu, MD.,PhD.

Role: primary

xuli@sysucc.org.cn

862087343582

Li Xu, MD., PhD.

Role: primary

xuli@sysucc.org.cn

8620-87343115

Zhishan Lin

Role: backup

linzhsh@sysucc.org.cn

8620-87343437

Other Identifiers

B2020-098-01

Identifier Type: -

Identifier Source: org_study_id