Combining Camrelizumab and Apatinib for Advanced Adrenocortical Carcinoma

Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma

This study is testing if combining two drugs, camrelizumab and apatinib, can help people with advanced adrenocortical carcinoma who haven't had success with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: chemotherapy, camrelizumab, apatinib
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT04318730 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of the PD-1 inhibitor camrelizumab in combination with the anti-tumor angiogenic drug apatinib for patients with recurrent or metastatic adrenocortical carcinoma (ACC) who have not responded to first-line treatments. The study aims to address the lack of effective second-line therapies for ACC, which is known for its aggressive nature and poor prognosis. Participants must have measurable disease and meet specific health criteria to ensure their safety during the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed metastatic or inoperable adrenocortical carcinoma that has progressed after first-line treatment.

Not a fit: Patients with early-stage ACC or those who have not undergone first-line treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective option for patients with advanced ACC who have limited treatment choices.

How similar studies have performed: Previous studies have shown promising results with PD-1 inhibitors in similar contexts, suggesting potential for success with this combination approach.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Xingchen Peng

Conditions Adrenocortical Carcinoma