- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04318730
Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma
December 16, 2022 updated by: Xingchen Peng, West China Hospital
Adrenocortical carcinoma (ACC) is a rare aggressive malignant tumor.
According to the literature, the 5-year survival rate of ACC is 12%-47%.
For patients with advanced ACC, mitotane alone or combined with traditional chemotherapy was the first-line standard treatment, but its progression-free survival was only about 1 year.
However, for patients who fail the first-line treatment, there is a lack of effective treatment.
For ACC patients who had failed first-line chemotherapy, a phase II clinical trial found that the objective response rate and the disease control rate of PD-1 inhibitor Keytruda were 14% and 64% respectively, and no grade 3 or 4 adverse events were observed.
Anti-tumor angiogenic drugs combined with PD-1 inhibitors have shown impressive clinical data in many solid tumors.
This study is aimed to evaluate the efficacy and safety of PD-1 inhibitor camrelizumab combined with apatinib in patients with recurrent or metastatic ACC after standard treatment failure, and to seek new treatment for this population.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
21
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital, Sichuan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed diagnosis of adrenocortical carcinoma;
- Patients with metastatic or inoperable adrenocortical carcinoma that has progressed, metastasized, or recurred after first-line standard treatment (mitotane monotherapy, chemotherapy alone, mitotane combined chemotherapy);
- Aged >=18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- At least one measurable lesion, according to RECIST 1.1;
- Major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion): HB≥80g/L, ANC≥1.5x10^9/L, PLT ≥80x10^9/L; TBIL≤1.5 ULN, ALT and AST ≤2.5 ULN, if there exists hepatic metastases, ALT and AST ≤5 ULN, Cr ≤1.5 ULN or CCr ≥60ml/min; INR or PT ≤1.5 ULN, APTT ≤1.5 ULN (if the patient is receiving anticoagulant therapy, PT and APTT should be within the expected treatment range); Cardiac Markers and BNP≤ULN;TSH≤ULN (If TSH is abnormal, T3 and T4 should be normal)
- Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment;
- Have signed consent form.
Exclusion Criteria:
- Patients with another primary malignancy within 5 years prior to starting the study drug, except for cured in situ cervical carcinoma and cured non-melanoma skin cancer;
- Have central nervous system metastasis with symptoms and need hormonal intervention;
- Had received strong CYP3A4 inhibitors within one week prior to enrollment or received strong CYP3A4 inducers within two weeks prior to enrollment;
- Poor control of high blood pressure (SBP>140mmHg or DBP>90mmHg);
- Congestive heart failure of New York Heart Association (NYHA) Class III or IV;
- Thromboembolic events occurred within 1 year prior to enrollment;
- ECG QT interval >500ms;
- Previous systemic immunosuppressive therapy;
- Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment;
- Received TKI treatment within 2 weeks prior to starting the study drug;
- Participate in clinical trials of other interventional drugs within 4 weeks prior to starting the study drug;
- Received systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to starting the study drug;
- An anti-tumor vaccine or a live vaccine was given within 4 weeks prior to starting the study drug;
- Major surgery or severe trauma within 4 weeks prior to starting the study drug;
- Severe infections occurred within 4 weeks prior to starting the study drug;
- Have an active autoimmune disease or a history of autoimmune diseases;
- Have a history of immunodeficiency;
- Have an active tuberculosis infection;
- Have active hepatitis;
- Patients with symptoms of gastrointestinal bleeding or risk of bleeding;
- Active infection, or patients are pregnant or breast-feeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
Camrelizumab was administered 200mg iv every 3 weeks, Apatinib was administered 250 mg p.o. qd.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate
Time Frame: up to 60 months
|
The rate of complete response and partial response.
|
up to 60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2021
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
April 1, 2025
Study Registration Dates
First Submitted
March 20, 2020
First Submitted That Met QC Criteria
March 20, 2020
First Posted (Actual)
March 24, 2020
Study Record Updates
Last Update Posted (Actual)
December 19, 2022
Last Update Submitted That Met QC Criteria
December 16, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Adrenal Gland Diseases
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Carcinoma
- Adrenocortical Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
- ChiCTR1900028111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adrenocortical Carcinoma
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National Cancer Institute (NCI)TerminatedRecurrent Adrenocortical Carcinoma | Stage III Adrenocortical Carcinoma | Stage IV Adrenocortical CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Adrenocortical Carcinoma | Stage III Adrenocortical Carcinoma | Stage IV Adrenocortical CarcinomaUnited States
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Dartmouth-Hitchcock Medical CenterM.D. Anderson Cancer Center; Dana-Farber Cancer Institute; AstraZeneca; Kentuckiana...CompletedNonresectable Adrenocortical CarcinomaUnited States
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National Cancer Institute (NCI)PfizerCompletedAdrenal Cortex NeoplasmsUnited States
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