Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

NCT04620473 | Withdrawn Phase 2

• 1 other identifier: MISC-Anlotinib+Capeox
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neoadjuvant Treatment; Rectal Cancer; Anlotinib

Keywords

Neoadjuvant Treatment; Rectal cancer; Anlotinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate（ORR）

  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

  an average of three months

Secondary Outcomes (6)

• Pathological complete response rate

  one month after surgery

• R0 resection rate

  one month after surgery

• Local disease recurrence time

  3 years after surgery

• Overall survive

  3 years after surgery

• Disease-free survival rate

  3 years after surgery

Study Arms (2)

Anlotinib+Capeox

EXPERIMENTAL

neoadjuvant treatment with Anlotinib hydrochloride combined with Capeox

Drug: Anlotinib+Capeox

Capeox

ACTIVE COMPARATOR

neoadjuvant treatment with Capeox

Drug: Capeox

Interventions

Anlotinib+Capeox DRUG

to use Anlotinib hydrochloride combined with Capeox in the neoadjuvant treatment of locally advanced rectal cancer

Anlotinib+Capeox

Capeox DRUG

to use Capeox in the neoadjuvant treatment of locally advanced rectal cancer

Capeox

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
• Participated in other anti-tumor drug clinical trials within four weeks;
• According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
• Female patients who are pregnant or breastfeeding;
• Known hypersensitivity to any study drug.

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending surgeon of gastrointestinal surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 9, 2020
• Study Start: November 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: October 1, 2024
• Last Updated: September 28, 2021

Record last verified: 2021-09