Actively Recruiting
Phase II Study of PD-1 Antibody Combined With Radiotherapy in Recurrent or Metastatic Adrenal Cortical Carcinoma
Led by Sun Yat-sen University · Updated on 2025-04-29
18
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Adrenal cortical cancer is an extremely rare and highly aggressive malignancy with an incidence of 0.7-2 per million people · year and a 5-year overall survival rate of 15-44%, among which the 5-year survival rate of stage IV cortical cancer is only 13% and the prognosis is poor. Complete surgical resection is one of the most important ways to cure cortical cancer, but the surgical trauma is large, the complications are high, the postoperative recovery of patients is slow, and the tumor is difficult to achieve complete resection, and the postoperative recurrence and metastasis rate of patients is high, even for localized cortical cancer (stage I-III), the recurrence and metastasis rate is still close to 60%. Recurrent or metastatic cortical cancer is mainly treated with drugs. However, the current first-line drug therapy is only 22.3% effective, the tumor progression-free time is 5.6 months, and the serious adverse reaction rate is as high as 58.1%. The effective rate of second-line treatment with chemotherapy and targeted drugs was less than 10%, and the tumor progression-free time was only 2.8 months. The Phase II study of PD-1 monoclonal antibody in the treatment of cortical cancer showed that the treatment effective rate was 23%, and the tumor progression-free survival time was 2.1 months, which was comparable to the first-line regimen, and has been approved by the guidelines for advanced cortical cancer. Radiation therapy has high efficiency and local control rate, small side effects, and can inhibit tumor growth, relieve local pressure and pain. However, it only has a good effect on the irradiated site, and it is difficult to inhibit the progression of non-radiotherapy lesions and the generation of other new lesions. The synergistic effect of immunotherapy combined with radiation therapy for metastatic stoves has been confirmed in many solid tumors such as kidney cancer, which can improve the local control rate of solid tumors and prolong the time of tumor progressive-free. In the early stage, this research team applied PD-1 monoclonal antibody combined with radiotherapy to treat recurrent or metastatic adrenal cortical cancer in many cases after receiving first-line drug therapy regimen, which not only achieved local control of the radiotherapy focus, but also inhibited the progression of other metastases, and achieved longer disease control effect.
CONDITIONS
Official Title
Phase II Study of PD-1 Antibody Combined With Radiotherapy in Recurrent or Metastatic Adrenal Cortical Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participated in this study and signed informed consent
- Patients 18 years old or older
- ECOG performance score of 2 points or less and expected survival of at least 6 months
- Pathological diagnosis of adrenal cortical carcinoma
- Unable or unwilling to undergo surgery for recurrent or metastatic adrenal cortical cancer
- Recurrence or metastasis after mitotan monotherapy, chemotherapy, or first-line mitotan plus cisplatin chemotherapy with disease progression
- At least one measurable lesion according to RECIST1.1 criteria
- Adequate organ function and laboratory values meeting specified blood, liver, kidney, and coagulation test standards
- Women of childbearing age must confirm non-pregnancy before enrollment and use effective contraception during treatment and for 4 weeks after
- Willingness to return for follow-up and good compliance
You will not qualify if you...
- Receiving anti-tumor monoclonal antibodies or other investigational drugs before enrollment
- Prior anti-PD-1 or PD-L1 monoclonal antibody therapy
- Previous radiotherapy to the lesion area
- Lesion invading the intestinal duct with contraindications to radiotherapy
- Known allergy to PD-1 monoclonal antibody or excipients
- Medical conditions interfering with oral medication, such as difficulty swallowing or intestinal obstruction
- Uncontrolled heart disease including heart failure NYHA class 2 or higher, unstable angina, recent myocardial infarction, arrhythmias requiring treatment
- Symptomatic central nervous system metastasis needing hormonal intervention or progressing brain metastases
- Serious infections within 4 weeks before starting study drug or active lung inflammation requiring antibiotics
- Recent systemic immunosuppressive therapy exceeding prednisone 10 mg/day
- Active chronic hepatitis B or C unless controlled or cured as specified
- Significant vital organ dysfunction or uncontrolled comorbidities
- History of interstitial lung disease or non-infectious pneumonia
- Pregnant or breastfeeding women and those unwilling to use contraception
- Mental illness, substance abuse history, or inability to give informed consent
- Other serious diseases or social/family risks making participation unsuitable
- Refusal or inability to sign informed consent
- Suspected or confirmed other primary cancers within 5 years except treated in situ cervical or skin cancers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
S
Shengjie Guo, doctor
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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