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UNKNOWNPHASE2

A Clinical Study to Compare the Efficacy and Safety of AK105 Plus Anlotinib and Capecitabine/Oxaliplatin (CapeOx) , Anlotinib Plus CapeOx, Bevacizumab Plus CapeOx

A Multi-center, Randomized, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AK105 Plus Anlotinib and CapeOx, Anlotinib in Combination With CapeOx Versus Bevacizumab in Combination With CapeOx in the Fisrt-line Treatment of Unresectable Metastatic Colorectal Cancer

NCT05068206•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

A clinical study to compare the efficacy and safety of AK105 plus anlotinib and Capecitabine/Oxaliplatin (CapeOx) , anlotinib plus CapeOx, bevacizumab plus CapeOx. A total of 120 cases will be enrolled to the group.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subjects shall volunteer to join in the research and sign the informed consent under the good compliance.
•Aged: 18-75 (calculated on the date of signing informed consent); the physical status of Eastern cooperative oncology group 0\~1; expected lifetime≥3 months.
•Unresectable and untreated metastatic colorectal adenocarcinoma patients diagnosed by histopathology Union for International Cancer Control (UICC) ,American Joint Committee on Cance( AJCC) tumor node metastasis staging system for colorectal cancer (8th edition in 2017) is clearly IV stage.
•Subjects who have not received systematic treatment for colorectal cancer before, including chemotherapy, targeted therapy and immunotherapy; Subjects with tumor recurrence or metastasis at least 6 months after the end of previous adjuvant or neoadjuvant chemotherapy.
•It can provide previously stored tumor tissue specimens or biopsy to collect tumor focus tissues for detecting programmed death 1 expression and kirsten rat sarcoma viral oncogene/neuroblastoma rat sarcoma viral oncogene mutation.
•According to RECIST 1.1 criterion, there is at least one measurable lesion. It is required that the selected target lesion has not received local treatment before, or the selected target lesion is located in the previous local treatment area, but it is determined as progressive disease by imaging examination.
•Good organ function (no blood transfusion, no hematopoietic stimulating factor, no infusion of albumin or blood products within 14 days before randomization).
•Female subjects of childbearing age should agree that contraceptive measures (such as abstinence, intrauterine device, contraceptive pills or condoms) must be used during the study and within 6 months after the end of the study; Serum pregnancy test was negative within 7 days before the study was enrolled, and it must be a non-lactating subject; Male subjects should agree that contraception must be used during the study period and within 6 months after the end of the study period.

Exclusion Criteria

•1\) Combined diseases and medical history:
•1. Other malignant tumors have occurred or are currently suffering at the same time within 3 years. The following conditions can be included: cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invasive basement membrane)\];
•2. Factors which affecting oral administration of drugs (such as inability to swallow, chronic diarrhoea and ileus, etc.);
•3. There is or tends to be gastrointestinal bleeding or perforation within 4 weeks before inclusion;
•4. Subjects with ulcerative colitis and Crohn's disease; Subjects with active inflammatory bowel disease within 4 weeks before inclusion;
•5. Uncontrollable pleural effusion and ascites requiring repeated drainage, and moderate and above hydropertcardium;
•6. Unmitigated toxic reactions above Common Terminology Criteria for Adverse Events S1 due to any previous treatment, excluding alopecia;
•7. Major surgical treatment, open biopsy or obvious traumatic injury were received within 28 days before inclusion (except tissue biopsy under gastrointestinal endoscope);
•8. Imaging(CT or MRI) showed that the tumor invaded large blood vessels or had unclear boundary with blood vessels;
•9. Subjects with hematemesis and hematochezia symptoms within 3 months before screening, and the daily bleeding volume is ≥ 2. 5 ml, or any bleeding event ≥ Common Terminology Criteria for Adverse Events S3, or subjects with any bleeding signs or medical history judged by researchers to be unsuitable for inclusion regardless of severity;
+18 more criteria

Locations (13)

First Hospital of Lanzhou University

Lanzhou, Gansu, China

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Sun Yixian Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Scinece and Technology

Luoyang, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Subei People's Hospital

Yangzhou, Jiangsu, China

Key Dates

Start Date

October 8, 2021

Primary Completion Date

December 1, 2023

Completion Date

June 1, 2024

Last Updated

October 20, 2021

Enrollment

120

ESTIMATED participants

Conditions

Unresectable Metastatic Colorectal Cancer

Interventions

AK105 injection

DRUG

Anlotinib hydrochloride capsule

DRUG

CapeOX

DRUG

Bevacizumab

DRUG

Contacts

Jin Li, Doctor

CONTACT

13761222111 lijin@csco.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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