OncoMatch/Clinical Trials/NCT04318730
Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma
Is NCT04318730 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Camrelizumab for adrenocortical carcinoma.
Treatment: Camrelizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: first-line standard treatment (mitotane, chemotherapy, mitotane combined chemotherapy) — first-line
progressed, metastasized, or recurred after first-line standard treatment (mitotane monotherapy, chemotherapy alone, mitotane combined chemotherapy)
Cannot have received: anti-PD-1 therapy
Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment
Cannot have received: anti-PD-L1 therapy
Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment
Cannot have received: anti-CTLA-4 therapy
Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment
Cannot have received: systemic immunosuppressive therapy
Previous systemic immunosuppressive therapy
Cannot have received: TKI
Received TKI treatment within 2 weeks prior to starting the study drug
Cannot have received: systemic corticosteroids or other immunosuppressants
Received systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to starting the study drug
Cannot have received: anti-tumor vaccine or live vaccine
An anti-tumor vaccine or a live vaccine was given within 4 weeks prior to starting the study drug
Lab requirements
Blood counts
HB≥80g/L, ANC≥1.5x10^9/L, PLT ≥80x10^9/L
Kidney function
Cr ≤1.5 ULN or CCr ≥60ml/min
Liver function
TBIL≤1.5 ULN, ALT and AST ≤2.5 ULN, if there exists hepatic metastases, ALT and AST ≤5 ULN
Cardiac function
Cardiac Markers and BNP≤ULN; ECG QT interval >500ms [excluded]; Congestive heart failure of NYHA Class III or IV [excluded]
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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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