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

Status

Recruiting

Intervention / Treatment

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:

  1. Histologically confirmed diagnosis of adrenocortical carcinoma;
  2. 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);
  3. Aged >=18 years;
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  5. At least one measurable lesion, according to RECIST 1.1;
  6. 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)
  7. Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment;
  8. Have signed consent form.

Exclusion Criteria:

  1. 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;
  2. Have central nervous system metastasis with symptoms and need hormonal intervention;
  3. Had received strong CYP3A4 inhibitors within one week prior to enrollment or received strong CYP3A4 inducers within two weeks prior to enrollment;
  4. Poor control of high blood pressure (SBP>140mmHg or DBP>90mmHg);
  5. Congestive heart failure of New York Heart Association (NYHA) Class III or IV;
  6. Thromboembolic events occurred within 1 year prior to enrollment;
  7. ECG QT interval >500ms;
  8. Previous systemic immunosuppressive therapy;
  9. Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment;
  10. Received TKI treatment within 2 weeks prior to starting the study drug;
  11. Participate in clinical trials of other interventional drugs within 4 weeks prior to starting the study drug;
  12. Received systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to starting the study drug;
  13. An anti-tumor vaccine or a live vaccine was given within 4 weeks prior to starting the study drug;
  14. Major surgery or severe trauma within 4 weeks prior to starting the study drug;
  15. Severe infections occurred within 4 weeks prior to starting the study drug;
  16. Have an active autoimmune disease or a history of autoimmune diseases;
  17. Have a history of immunodeficiency;
  18. Have an active tuberculosis infection;
  19. Have active hepatitis;
  20. Patients with symptoms of gastrointestinal bleeding or risk of bleeding;
  21. 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:
  • Apatinib

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.

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

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.

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