Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587802
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Phase II Study of PD-1 Antibody Combined with Radiotherapy in Recurrent or Metastatic Adrenal Cortical Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Study of PD-1 Antibody Combined with Radiotherapy in Recurrent or Metastatic Adrenal Cortical Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adrenal cortical cancer is an extremely rare and highly aggressive malignancy with an incidence of 07-2 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 223 effective the tumor progression-free time is 56 months and the serious adverse reaction rate is as high as 581
The effective rate of second-line treatment with chemotherapy and targeted drugs was less than 10 and the tumor progression-free time was only 28 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 21 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
Recurrent or metastatic cortical cancer is mainly treated with drugs However the current first-line drug therapy is only 223 effective the tumor progression-free time is 56 months and the serious adverse reaction rate is as high as 581
The effective rate of second-line treatment with chemotherapy and targeted drugs was less than 10 and the tumor progression-free time was only 28 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 21 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
Detailed Description:
Adrenocortical Carcinoma ACC is an extremely rare and highly aggressive malignant tumor with an incidence of 07-2 per million people and poor prognosis The 5-year overall survival rate is 15-44 and the 5-year survival rate of stage IV ACC is only 13 Surgical complete resection R0 is one of the most important ways to cure ACC However even for localized ACC stage I-III there is still a recurrence and metastasis rate of nearly 60 due to reasons including surgical failure to achieve R0 resection tumor rupture and postoperative hematologic and lymphatic metastasis Recurrent or metastatic ACC is mainly treated with systemic drugs mitotan monotherapy or mitotan combined with cisplatin based chemotherapy mitotan etoposide adriamycin and cisplatin EDP-M protocol is currently the first-line protocol for advanced ACC but the objective response rate ORR of EDP-M is only 223 the progression-free survival PFS is 56 months and the grade 3-4 adverse reactions are as high as 581 Treatment options for patients with recurrent or metastatic ACC after first-line treatment progress are more limited and less effective The ORR of second-line chemotherapy for advanced ACC was less than 10 Targeted drugs such as Sunitinib for second-line treatment of advanced ACC had an ORR of 0 and PFS was only 28 months Five clinical studies have been conducted to investigate the efficacy of immunotherapy for adrenal cortical cancer The results of a phase II study on the treatment of ACC with PD-1 monoclonal antibody showed that ORR could reach 23 which is the regimen with the highest objective response rate at present Therefore the guidelines recommend PD-1 monoclonal antibody for advanced ACC but the PFS of PD-1 monoclonal antibody is only 21 months Therefore how to prolong PFS with high ORR is a difficult problem in the treatment of advanced ACC
For recurrent or metastatic ACC surgical palliative resection of metastasis can reduce tumor or alleviate symptoms However due to large surgical trauma high complications slow postoperative recovery of patients difficult R0 resection of tumors and high postoperative recurrence and metastasis rate of patients it is still controversial whether palliative surgery for advanced ACC can bring survival benefits to patients The guidelines also recommend that radiotherapy can be used for advanced ACC with high ORR and local control rate small side effects inhibiting tumor growth relieving local pressure and pain However radiotherapy is a local treatment that only has a good effect on the irradiated site and it is difficult to inhibit the progression of non-radiotherapy lesions and the emergence of other new lesions Therefore the effect of radiotherapy alone on the overall disease control of patients with advanced ACC recurrence or metastasis is still unsatisfactory
The synergistic effect of immunotherapy combined with radiotherapy for metastatic stoves has been demonstrated in many solid tumors such as kidney cancer The ORR of advanced renal clear cell carcinoma treated with PD-1 monoclonal antibody alone was only 365 the median PFS time was 71 months and the 2-year PFS rate was 223 while the ORR of advanced renal clear cell carcinoma treated with PD-1 monoclonal antibody combined with radiotherapy was 63 PFS was 156 months and the 2-year PFS rate was 45 Therefore immunotherapy combined with radiotherapy can improve the local control rate and prolong the PFS time of metastatic renal carcinoma The ORR of PD-1 monoclonal antibody monotherapy for advanced ACC was 23 and PFS was 21 months Although the ORR was similar to that of EDP-M first-line regimen the PFS was shorter Therefore it is of great clinical significance to explore whether PD-1 monoclonal antibody combined with radiotherapy for advanced ACC can obtain higher ORR and longer PFS
In the early stage this research team applied PD-1 monoclonal antibody combined with SBRT to treat recurrent or metastatic adrenal cortical cancer in multiple cases of recurrent or metastatic ACC after treatment with first-line EDP-M protocol which not only achieved local control of radiotherapy lesions but also inhibited the progression of other metastasies and achieved longer disease control effect ORR 47 PFS July On the basis of previous practice our team plans to further conduct prospective exploratory clinical research on the efficacy and safety of PD-1 monoclonal antibody combined with radiotherapy in the treatment of recurrent or metastatic adrenal cortical carcinoma so as to provide more safe and effective treatment options for this rare tumor
Main purpose
To observe and evaluate the progression-free survival time of PD-1 monoclonal antibody combined with radiotherapy in the treatment of recurrent or metastatic adrenal cortical carcinoma
Secondary purpose
To observe and evaluate the secondary efficacy indexes and safety of PD-1 monoclonal antibody combined with radiotherapy in the treatment of recurrent or metastatic adrenal cortical carcinoma
For recurrent or metastatic ACC surgical palliative resection of metastasis can reduce tumor or alleviate symptoms However due to large surgical trauma high complications slow postoperative recovery of patients difficult R0 resection of tumors and high postoperative recurrence and metastasis rate of patients it is still controversial whether palliative surgery for advanced ACC can bring survival benefits to patients The guidelines also recommend that radiotherapy can be used for advanced ACC with high ORR and local control rate small side effects inhibiting tumor growth relieving local pressure and pain However radiotherapy is a local treatment that only has a good effect on the irradiated site and it is difficult to inhibit the progression of non-radiotherapy lesions and the emergence of other new lesions Therefore the effect of radiotherapy alone on the overall disease control of patients with advanced ACC recurrence or metastasis is still unsatisfactory
The synergistic effect of immunotherapy combined with radiotherapy for metastatic stoves has been demonstrated in many solid tumors such as kidney cancer The ORR of advanced renal clear cell carcinoma treated with PD-1 monoclonal antibody alone was only 365 the median PFS time was 71 months and the 2-year PFS rate was 223 while the ORR of advanced renal clear cell carcinoma treated with PD-1 monoclonal antibody combined with radiotherapy was 63 PFS was 156 months and the 2-year PFS rate was 45 Therefore immunotherapy combined with radiotherapy can improve the local control rate and prolong the PFS time of metastatic renal carcinoma The ORR of PD-1 monoclonal antibody monotherapy for advanced ACC was 23 and PFS was 21 months Although the ORR was similar to that of EDP-M first-line regimen the PFS was shorter Therefore it is of great clinical significance to explore whether PD-1 monoclonal antibody combined with radiotherapy for advanced ACC can obtain higher ORR and longer PFS
In the early stage this research team applied PD-1 monoclonal antibody combined with SBRT to treat recurrent or metastatic adrenal cortical cancer in multiple cases of recurrent or metastatic ACC after treatment with first-line EDP-M protocol which not only achieved local control of radiotherapy lesions but also inhibited the progression of other metastasies and achieved longer disease control effect ORR 47 PFS July On the basis of previous practice our team plans to further conduct prospective exploratory clinical research on the efficacy and safety of PD-1 monoclonal antibody combined with radiotherapy in the treatment of recurrent or metastatic adrenal cortical carcinoma so as to provide more safe and effective treatment options for this rare tumor
Main purpose
To observe and evaluate the progression-free survival time of PD-1 monoclonal antibody combined with radiotherapy in the treatment of recurrent or metastatic adrenal cortical carcinoma
Secondary purpose
To observe and evaluate the secondary efficacy indexes and safety of PD-1 monoclonal antibody combined with radiotherapy in the treatment of recurrent or metastatic adrenal cortical carcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None