Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients

Colorectal Cancer Clinical Trial

— ALTER-C-002  

Official title:

An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type Patients With Metastatic Colorectal Carcinoma as 1st Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080843
• Other study ID #: ALTER-C-002
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy, patients will receive capecitabine and anlotinib as maintenance therapy until tumor progression.In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with CAPEOX in treatment of patients with mCRC. The patients who are pathologically confirmed as RAS and BRAF wild-type mCRC will be enrolled.

Condition or disease Invention/treatment Phase Colorectal Cancer Drug: Anlotinib Hydrochloride Drug: Capecitabine Drug: Oxaliplatin Phase 2

Description:

This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy, patients will receive capecitabine and anlotinib as maintenance therapy until tumor progression.In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with CAPEOX in treatment of patients with Metastatic Colorectal Carcinoma(mCRC).Primary Efficacy Endpoint: Objective Response Rate (ORR), Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Disease Control Rate (DCR) and duration of response(DoR). Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• At least one measurable lesion (the length of spiral CT scan (> 10mm) meets the requirements of RESCIST 1.1) is found in patients with HCC confirmed by histopathology or cytology or who meet the clinical diagnostic criteria.

• = 18 and = 75 years of age

• ECOG performance status of 0-1

• No prior treatment for advanced disease (adjuvant therapy allowed)

• Life expectancy of at least 3 months

• The main organs are functioning normally.

• Neutrophils count =/> 1.5 x 109/L, platelets count =/> 100 x 109/L, HGB =/> 90 g/L

• total bilirubin =/< 1.5 x UNL • SGOT and SGPT =/< 2.5 x UNL (=/< 5 x UNL in patients with liver metastases)

• Creatinine =/< 1.5 x UNL

• Patients who are molecularly diagnosed as having RAS and BRAF wild-type mCRC are Histologically/cytologically confirmed as advanced, colorectal cancer.

• Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

Exclusion Criteria:

• Pregnant or lactating women.

• Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.

• Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg), patients with myocardial infarction, arrhythmias with poor control (including QTC interval > 450 ms) and cardiac insufficiency of grade II according to NYHA standard.

• with bleeding tendency or undergoing thrombolysis or anticoagulation therapy.

• serious uncontrolled intercurrence infection.

• Proteinuria = 2+ (1.0g/24hr).

• Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness.

• Within 6 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.

• Have a history of mental illness or psychotropic drug abuse.

• Patients with a history of immunodeficiency(or autoimmue disease), or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and hematopoietic stem cell transplantation.

• Patients who are allergic to components of Capecitabine preparations, Oxaliplatin injection and anlotinib preparations.

• According to the researchers' judgment, there are serious concomitant diseases that endanger patient safety or prevent patients from completing the study.

• Patients who have received prior systemic chemotherapy, targeted therapy, immunity therapy or any medication within 30 days.

Related Conditions & MeSH terms

• Colonic Diseases
• Colorectal Cancer
• Colorectal Neoplasms
• Digestive System Diseases
• Digestive System Neoplasms
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Intestinal Diseases
• Intestinal Neoplasms
• Neoplasms
• Neoplasms by Site
• RAS and BRAF Wild-type
• Rectal Diseases

Intervention

Drug:
• Anlotinib Hydrochloride
Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off.
• Capecitabine
Capecitabine is a capsule in the form of 500 mg, orally, 850 mg/m2, twice daily, 2 weeks on/1 week off.
• Oxaliplatin
Oxaliplatin 130 mg/m2,D1

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate(ORR)	using RECIST version 1.1	Every 2 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary	Progression-free survival (PFS)	using RECIST version 1.1	every 2 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary	Disease control rate (DCR)	using RECIST version 1.1	every 2 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary	Duration of Response (DoR)	using RECIST version 1.1	every 2 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary	Safety: NCI CTC AE Version 4.0.3	Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 4.0.3	from day 1 of first dosing to 30 days after permanent discontinuation of Anlotinib