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ACTIVE NOT RECRUITING
NCT04715633
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: PD-1 Inhibitors (Camrelizumab) Combined With VEGF Inhibitors (Apatinib) for Locally Advanced dMMR/MSI-H Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2020-12-01

Completion Date

2025-07-31

Last Updated

2024-07-09

Healthy Volunteers

No

Interventions

DRUG

PD-1 inhibitor plus VEGF inhibitors

Camrelizumab 200mg IV every 3 weeks; Apatinib 250mg QD day 1-14. Rescue chemotherapy: Oxaliplatin 130mg/m2 IV drip Q3W d1+Capecitabine 1000mg/m2 QD d1-d14 Rescue chemoradiotherapy: Long-course radiotherapy +Capecitabine 825mg/m2 QD d1-d14

Locations (1)

651 Dongfeng Road East

Guangzhou, Guangdong, China