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Ovarian clear cell carcinoma (OCCC) is a relatively rare but highly malignant epithelial ovarian cancer, accounting for 5%-10% of all ovarian cancers. The incidence of this tumor has significant racial disparity, with the highest incidence in Asians, accounting for 25% of ovarian cancer patients, while in European and American ovarian cancer patients, it only accounts for 4.8%. Due to the unique biological behavior of OCCC, it responds poorly to traditional platinum-based chemotherapy regimens, and the prognosis of patients with advanced and recurrent disease is extremely poor.
OCCC has low sensitivity to platinum-based chemotherapy, especially in recurrent or persistent disease, and the objective response rate (ORR) of chemotherapy is usually less than 10%. Although immunotherapy has shown good results in OCCC, 60% of patients still cannot shrink their tumors after using combination regimens, and 50% of patients will still progress after 6.9 months of treatment. The question of how to treat OCCC after progression on immunotherapy remains a pressing issue. Sacituzumab (SKB264) is an antibody-drug conjugate (ADC) consisting of a humanized anti-trophoblast cell surface antigen 2 (Trop-2) monoclonal antibody conjugated to T030. In the KL264-I-01 study (which included patients with OCCC) in patients with recurrent ovarian cancer, single-agent Sacituzumab achieved an objective response rate of 40%, superior to conventional chemotherapy, with manageable toxicity. OCCC patients who progress on immunotherapy face a dilemma of limited treatment options. Based on this current situation and the potential activity of Sacituzumab the investigators propose Sacituzumab as an option for patients with OCCC after immunotherapy progression.
Ovarian clear cell carcinoma (OCCC) is a relatively rare but highly malignant epithelial ovarian cancer, accounting for 5%-10% of all ovarian cancers. The incidence of this tumor has significant racial disparity, with the highest incidence in Asians, accounting for 25% of ovarian cancer patients, while in European and American ovarian cancer patients, it only accounts for 4.8%. Due to the unique biological behavior of OCCC, it responds poorly to traditional platinum-based chemotherapy regimens, and the prognosis of patients with advanced and recurrent disease is extremely poor.
OCCC has low sensitivity to platinum-based chemotherapy, especially in recurrent or persistent disease, and the objective response rate (ORR) of chemotherapy is usually less than 10%. The OCCC tumor microenvironment indicates that OCCC is a "hot tumor," suggesting that patients may benefit from immunotherapy. This benefit has been confirmed in clinical studies. Although immunotherapy has shown good results in OCCC, 60% of patients still cannot shrink their tumors after using combination regimens, and 50% of patients will still progress after 6.9 months of treatment. The question of how to treat OCCC after progression on immunotherapy remains a pressing issue. Sacituzumab (SKB264) is an antibody-drug conjugate (ADC) consisting of a humanized anti-trophoblast cell surface antigen 2 (Trop-2) monoclonal antibody conjugated to T030. In the KL264-I-01 study (which included patients with OCCC) in patients with recurrent ovarian cancer, single-agent Sacituzumab achieved an objective response rate of 40%, superior to conventional chemotherapy, with manageable toxicity. OCCC patients who progress on immunotherapy face a dilemma of limited treatment options. Based on this current situation and the potential activity of Sacituzumab the investigators propose Sacituzumab as an option for patients with OCCC after immunotherapy progression.
The investigators plan to conduct a prospective, real-world clinical study to enroll patients with OCCC who have developed resistance to immunotherapy and receive Sacituzumab (5 mg/kg intravenous infusion, 2 weeks of treatment). The investigators will prospectively observe and collect treatment responses, efficacy data, and safety events, and compare the efficacy with that of a historical cohort of immunotherapy-resistant patients who received traditional chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab Group | The patient received 5 mg/kg of Sacituzumab per two weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The proportion of patients whose tumor volume was reduced by more than 30% and maintained for 4 weeks | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Any adverse events that occur during drug treatment | 2 years |
| Overall survival | Time from enrollment to death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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This study enrolled patients with pathologically diagnosed OCCC who had progressed after treatment with immune checkpoint inhibitors, including anti-PD-1, PD-L1, and PD-1/PD-L1+CTLA4, and subsequently received ruconazole (regardless of the number of lines of therapy received prior to immunotherapy).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanan Lu, master | Contact | +8615868090553 | luyn3@mail2.sysu.edu.cn | |
| Jing Li, doctor | Contact | +8615915893493 | lijing228@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jing Li, Doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18081792 | Background | Takano M, Sugiyama T, Yaegashi N, Sakuma M, Suzuki M, Saga Y, Kuzuya K, Kigawa J, Shimada M, Tsuda H, Moriya T, Yoshizaki A, Kita T, Kikuchi Y. Low response rate of second-line chemotherapy for recurrent or refractory clear cell carcinoma of the ovary: a retrospective Japan Clear Cell Carcinoma Study. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):937-42. doi: 10.1111/j.1525-1438.2007.01158.x. Epub 2007 Dec 13. | |
| 10861437 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| From enrollment to 2 years after treatment completion |
| Progression free survival | Time from enrollment to disease progression | From enrollment to 2 years after treatment completion |
| Background |
| Sugiyama T, Kamura T, Kigawa J, Terakawa N, Kikuchi Y, Kita T, Suzuki M, Sato I, Taguchi K. Clinical characteristics of clear cell carcinoma of the ovary: a distinct histologic type with poor prognosis and resistance to platinum-based chemotherapy. Cancer. 2000 Jun 1;88(11):2584-9. |
| 34247767 | Background | Gadducci A, Multinu F, Cosio S, Carinelli S, Ghioni M, Aletti GD. Clear cell carcinoma of the ovary: Epidemiology, pathological and biological features, treatment options and clinical outcomes. Gynecol Oncol. 2021 Sep;162(3):741-750. doi: 10.1016/j.ygyno.2021.06.033. Epub 2021 Jul 8. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |