Clinical trial NCT04620473: Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Neoadjuvant Treatment
Rectal Cancer
Anlotinib
Keywords: Neoadjuvant Treatment
Rectal cancer
Anlotinib
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Objective Response Rate（ORR）
timeFrame: an average of three months
Secondary outcomes:
measure: Pathological complete response rate
timeFrame: one month after surgery
measure: R0 resection rate
timeFrame: one month after surgery
measure: Local disease recurrence time
timeFrame: 3 years after surgery
measure: Overall survive
timeFrame: 3 years after surgery
measure: Disease-free survival rate
timeFrame: 3 years after surgery
measure: Postoperative complications
timeFrame: one month after surgery
Other outcomes:
Locations:
Study officials:
References: