Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal cancer-a Prospective, Open, Single Center and Randomized Controlled Phase Ⅱ Clinical Trial

Shanghai Minimally Invasive Surgery Center0 sitesNovember 1, 2023

ConditionsNeoadjuvant Treatment Rectal Cancer Anlotinib

InterventionsAnlotinib+Capeox Capeox

DrugsAnlotinib+Capeox Capeox

Overview

Phase: Phase 2
Intervention: Anlotinib+Capeox
Conditions: Neoadjuvant Treatment
Sponsor: Shanghai Minimally Invasive Surgery Center
Primary Endpoint: Objective Response Rate（ORR）
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Prospectively Investigate the effectiveness and safety of anlotinib hydrochloride combined with Capeox in neoadjuvant treatment of patients with locally advanced rectal cancer.

Registry

clinicaltrials.gov

Start Date

November 1, 2023

End Date

October 1, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Minimally Invasive Surgery Center

Responsible Party

Principal Investigator

Cai Zhenghao

Attending surgeon of gastrointestinal surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai Minimally Invasive Surgery Center

Eligibility Criteria

Inclusion Criteria

•Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
•Male or female patients between the ages of 18-75;
•Patients diagnosed as rectal adenocarcinoma by histology or cytology;
•Stage: Locally advanced stage (T3-4N0M0 or T1-4N+M0);
•Evaluation of middle and low rectal cancer with the lower pole of the tumor less than 12 cm from the anal margin by MRI;
•Have not received other anti-angiogenic drugs or chemotherapy drugs in the past;
•ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
•Has sufficient organ and bone marrow function

Exclusion Criteria

•Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)\];
•A distant transfer occurs;
•Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
•Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
•Patients with any severe and/or uncontrollable disease；
•Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
•Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
•Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping;
•Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
•Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;

Arms & Interventions

Anlotinib+Capeox

neoadjuvant treatment with Anlotinib hydrochloride combined with Capeox

Intervention: Anlotinib+Capeox

Capeox

neoadjuvant treatment with Capeox

Intervention: Capeox

Outcomes

Primary Outcomes

Objective Response Rate（ORR）

Time Frame: an average of three months

Refers to the proportion of subjects whose tumors have shrunk to a certain amount and maintained for a certain period of time in the FAS concentration, including CR and PR cases