Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04318730

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

Led by West China Hospital · Updated on 2024-07-17

21

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of adrenocortical carcinoma
  • Metastatic or inoperable adrenocortical carcinoma that progressed, metastasized, or recurred after first-line standard treatment
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • At least one measurable lesion according to RECIST 1.1
  • Adequate major organ function within 28 days before treatment (including hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, creatinine, coagulation, cardiac markers, thyroid function)
  • Use of appropriate contraception from start of treatment to 120 days after treatment ends
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Another primary malignancy within 5 years prior to study start, except cured in situ cervical carcinoma or non-melanoma skin cancer
  • Symptomatic central nervous system metastasis requiring hormonal treatment
  • Use of strong CYP3A4 inhibitors within 1 week or inducers within 2 weeks before enrollment
  • Poorly controlled high blood pressure (SBP >140 mmHg or DBP >90 mmHg)
  • Congestive heart failure New York Heart Association Class III or IV
  • Thromboembolic events within 1 year before enrollment
  • ECG QT interval longer than 500 ms
  • Prior systemic immunosuppressive therapy
  • Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
  • Tyrosine kinase inhibitor treatment within 2 weeks prior to study drug
  • Participation in other interventional drug trials within 4 weeks prior to study drug
  • Systemic corticosteroid or immunosuppressant therapy within 2 weeks prior to study drug
  • Anti-tumor or live vaccine within 4 weeks prior to study drug
  • Major surgery or severe trauma within 4 weeks prior to study drug
  • Severe infections within 4 weeks prior to study drug
  • Active autoimmune disease or history of autoimmune disease
  • History of immunodeficiency
  • Active tuberculosis infection
  • Active hepatitis
  • Symptoms or risk of gastrointestinal bleeding
  • Active infection, pregnancy, or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

X

Xingchen Peng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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