Patients will undergo a 2-week screening period and a 4-week core treatment period, and eligible patients who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance.

Patients in Cohort 1 will receive 4 escalating doses (2, 5, 10 and 25 μg) of M701 on Days 1, 8, 15 and 22. The maintenance dose during extended treatment period is 25 μg.

Cohort 1 of M701

Patients in Cohort 2 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 25 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.

Cohort 2 of M701

Patients in Cohort 3 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.

Cohort 3 of M701

Patients in Cohort 4 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 200 μg.

Cohort 4 of M701

Patients in Cohort 5 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 150 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.

Cohort 5 of M701

Patients in Cohort 6 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 200 μg, and the maintenance dose during core treatment period and extended treatment period is 400 μg.

Cohort 6 of M701

Patients in Cohort 7 will receive a starting doseon Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 250 μg, and the maintenance dose during core treatment period and extended treatment period is 500 μg.

Cohort 7 of M701

To evaluate the efficacy and safety of the AbsnowTM II absorbable atrial septal defect occluder system in the treatment of atrial septal defect.

Absnow II Absorbable Atrial Septal Defect Occluder System

The Cera atrial septal defect occluder produced by the same company serves as the control group.

Cera Atrial Septal Defect Occluder

Adoption of traditional surgical methods for oral cancer resection and defect repair; no auxiliary technologies such as mixed reality or virtual guides are used, and tumor resection and flap repair are completed relying on the clinician's clinical experience.

Application of Mixed Reality (MR) technology based on the UE5 engine to assist in oral cancer resection and defect repair; realize real-time three-dimensional visualization of surgical plans, precise resection of oral cancer, "tailor-made" flap harvesting, and match the shape and volume of the defect site.

Intervention Description: Assisted oral cancer resection and defect reconstruction using MR technology based on UE5 engine, to achieve real-time stereoscopic visualization of surgical planning, accurate tumor resection and personalized free flap harvest, ensuring the reconstructed flap matches the defect site in morphology and volume.

Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction

Application of virtual surgical guide technology to assist in oral cancer resection and defect repair; assist surgery relying on pre-designed and manufactured guides to improve surgical standardization; guide printing is required before surgery, and the plan cannot be adjusted in real time during surgery.

Intervention Description: Assisted oral cancer resection and defect reconstruction using virtual surgical guide technology, with surgery performed under the guidance of preoperatively designed and fabricated guides to improve surgical standardization.

Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

M701의 1번 코호트, M701의 2번 코호트, M701의 3번 코호트, M701의 4번 코호트, M701의 5번 코호트, M701의 6번 코호트, M701의 7번 코호트

앱스노우 II 흡수성 심방중격결손 폐쇄 시스템, 세라 심방중격결손 폐쇄기

언리얼 엔진 5(UE5) 기반 혼합 현실(MR) 기술을 활용한 구강암 절제 및 결손 부위 재건, 가상 수술 가이드 기술을 활용한 구강암 절제 및 결손 부위 재건