To evaluate the safety and effectiveness of Ivonescimab combined with intraperitoneal paclitaxel (IP PTX) in patients with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA).
Age 18 years and above. There will be no upper age restriction
ECOG performance status 0-2
Participants must have histologically confirmed diagnosis of unresectable metastatic AA. The determination of appendiceal origin may rely on pathologic features combined with clinical or radiographic evidence in the event that the appendix remains in situ.
Participants will have undergone no more than two prior lines of systemic therapy. The last dose of systemic therapy will have been no less than 2 weeks prior to initiation of therapy.
Metastases outside the peritoneal cavity, with exception of limited metastases to the thoracic cavity and/or limited retroperitoneal lymphadenopathy
Previous surgery that would preclude safe diagnostic laparoscopy with port placement
Current presence of significant radiographic or clinical/radiographic manifestations of gastrointestinal obstruction. History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment
Recent history (within the last 30 days) of large volume ascites requiring repeated paracenteses. Large-volume ascites that has resolved with prior systemic therapies is not considered Exclusionary.
M.D. Anderson Cancer Center
Lead sponsor
Cancer Prevention Research Institute of Texas
Collaborator
Summit Therapeutics
Collaborator