PD-1 Inhibitors Combined With VEGF Inhibitors for Locally Advanced dMMR/MSI-H Colorectal Cancer

Phase 2 Active not recruiting 53 enrolled Sun Yat-sen University Guangdong Provincial Hospital of Traditional Chinese Medicine · collab Guangdong Provincial People's Hospital · collab

NaSingle-groupOpen-labelTreatment

Summary

In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 inhibitors (Camrelizumab) plus VEGF inhibitor (Apatinib) for dMMR/MSI-H colorectal cancer staged as locally advanced (cT3-4N+/-M0 for rectal cancer, cT4 or cT3 with extramural extension ≥5mm for colon cancer). Radiological evaluation will be preformed after 4 cycles of treatment. Patients (either with colon or rectal cancer) who achieve complete clinical response will be offered the choice of Watch \& Wait.

Timeline

Start: 2020-12-01
Primary completion: 2023-08-30
Completion: 2025-07-31

Publications

Results Yu JH, Xiao BY, Li DD, Jiang W, Ding Y, Wu XJ, Zhang RX, Lin JZ, Wang W, Han K, Kong LH, Zhang XK, Chen BY, Mei WJ, Pan ZZ, Tang JH, Zhang XS, Ding PR. Neoadjuvant camrelizumab plus apatinib for locally advanced microsatellite instability-high or mismatch repair-deficient colorectal cancer (NEOCAP): a single-arm, open-label, phase 2 study. Lancet Oncol. 2024 Jul;25(7):843-852. doi: 10.1016/S1470-2045(24)00203-1. Epub 2024 Jun 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Camrelizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Rivoceranib	Small molecule	250 mg	Oral
Background	Capecitabine	Small molecule	1000 mg/m2	—
Background	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

PD-1 Inhibitors Combined With VEGF Inhibitors for Locally Advanced dMMR/MSI-H Colorectal Cancer

Summary

Timeline

Publications

Drugs

Indications