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

• ClinicalTrials.gov Identifier: NCT04620473
• Recruitment Status: Withdrawn
• First Posted: November 9, 2020
• Last Update Posted: September 28, 2021
• Sponsor: Shanghai Minimally Invasive Surgery Center
• Information provided by (Responsible Party): Cai Zhenghao, Shanghai Minimally Invasive Surgery Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Neoadjuvant Treatment; Rectal Cancer; Anlotinib	Drug: Anlotinib+Capeox; Drug: Capeox	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Estimated Study Start Date: November 1, 2023
• Estimated Primary Completion Date: December 1, 2023
• Estimated Study Completion Date: October 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Anlotinib+Capeox; neoadjuvant treatment with Anlotinib hydrochloride combined with Capeox	Drug: Anlotinib+Capeox; to use Anlotinib hydrochloride combined with Capeox in the neoadjuvant treatment of locally advanced rectal cancer
Active Comparator: Capeox; neoadjuvant treatment with Capeox	Drug: Capeox; to use Capeox in the neoadjuvant treatment of locally advanced rectal cancer

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Pathological complete response rate [ Time Frame: one month after surgery ]
   Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0)
2. R0 resection rate [ Time Frame: one month after surgery ]
   Refers to the surgically removed tissue without residual cancer cells
3. Local disease recurrence time [ Time Frame: 3 years after surgery ]
   Refers to the tumor reappearing at or near the same site as the primary cancer. The starting time is the first day after surgery.
4. Overall survive [ Time Frame: 3 years after surgery ]
   Refers to the time from the start of randomization to death due to any cause. The starting time is the first day after surgery.
5. Disease-free survival rate [ Time Frame: 3 years after surgery ]
   It refers to the time from the beginning of randomization to the incurable resection, local recurrence or metastasis, or death from any cause. The starting time is the first day after surgery.
6. Postoperative complications [ Time Frame: one month after surgery ]
   Postoperative complications

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. 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)];
2. A distant transfer occurs;
3. Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
4. Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
5. Patients with any severe and/or uncontrollable disease；
6. 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
7. 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;
8. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping;
9. 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
10. 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;
11. People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
12. Participated in other anti-tumor drug clinical trials within four weeks;
13. 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;
14. Female patients who are pregnant or breastfeeding;
15. Known hypersensitivity to any study drug.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Cai Zhenghao, Attending surgeon of gastrointestinal surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai Minimally Invasive Surgery Center
• ClinicalTrials.gov Identifier: NCT04620473
• Other Study ID Numbers: MISC-Anlotinib+Capeox
• First Posted: November 9, 2020
• Last Update Posted: September 28, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Cai Zhenghao, Shanghai Minimally Invasive Surgery Center:

Neoadjuvant Treatment; Rectal cancer; Anlotinib

Additional relevant MeSH terms:

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Oxaliplatin; Capecitabine; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action