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

NCT04454905 | Unknown Phase 2

• 1 other identifier: B2020-098-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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).

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause.

  Three years

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Three years

• Overall Survival (OS)

  Three years

• Disease Control Rate (DCR)

  Two years

• Duration of Response (DoR)

  Two years

• Time to Progression (TTP)

  Two years

Study Arms (1)

Camrelizumab combination with Apatinib

EXPERIMENTAL

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

Drug: Camrelizumab; Drug: Apatinib

Interventions

Camrelizumab DRUG

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

Also known as: Camrelizumab for Injection

Camrelizumab combination with Apatinib

Apatinib DRUG

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

Also known as: Rivoceranib

Camrelizumab combination with Apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (2)

Li Xu

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

camrelizumab; Injections; apatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Minshan Chen, MD., PhD.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xu, MD., PhD.

CONTACT

+862087343582; xuli@sysucc.org.cn

Zhishan Lin

CONTACT

862087343437; linzhsh@sysucc.org.cn

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: Professor

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: August 1, 2020
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

CN (2)