This protocol applies to patients diagnosed with gestational choriocarcinoma who have been classified as high risk by the WHO modified prognostic index for gestational trophoblastic neoplasm (GTN) — specifically those with a score of 7 or more — and whose disease has become resistant to chemotherapy.
A WHO modified prognostic score of 7 or higher places patients in the high-risk GTN category. At this threshold, multi-agent chemotherapy is the initial standard of care; single-agent chemotherapy is appropriate only for patients with a score below 7. High-risk patients whose disease progresses on or fails to respond to chemotherapy represent a distinct subgroup addressed by this protocol.
For high-risk gestational choriocarcinoma that is resistant to chemotherapy, immunotherapy-based strategies have been investigated. These include agents that act on immune checkpoint pathways, as well as combinations of immune checkpoint inhibition with targeted antiangiogenic therapy. The complete regimen details, agent selection, and clinical sequencing are available in the full structured protocol.
DOI: 10.1136/ijgc-2023-004704
Patients with gestational choriocarcinoma who reach a WHO modified prognostic index score for GTN of 7 or higher should initially be treated with multi-agent chemotherapy.
Consider using single-agent chemotherapy in low-risk (score <7) and multi-agent chemotherapy in high risk (score of 7 or more).
Recent trials have been investigating anti-PD-L1 immunotherapy agents (pembrolizumab, nivolumab, and avelumab) in the treatment of chemo-resistant GTN, and are mentioned accordingly in recent NCCN guidelines.
A recent phase II, single arm, prospective trial (CAP 01) evaluated the activity and safety of camrelizumab (PD-1 inhibitor) plus apatinib (vascular endothelial growth factor (VEGF) receptor inhibitor) in patients with high-risk chemo-refractory or relapsed gestational trophoblastic neoplasia.
Emerging data on immune checkpoint inhibitors (with anti-angiogenic agents) have highlighted the potential application of immunotherapy in heavily pre-treated patients.
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