Patient-reported Outcomes (PRO) and Treatment Outcomes of Chinese Patients With MSS-type Advanced Colorectal Cancer Who Received the Zidovudine Combination Regimen in the Real World

West China Hospital300 enrolled

Overview

The Chidamide + sintilimab ± bevacizumab regimen has become a post-treatment option for clinicians and patients after being included in the guidelines. The CAPability-01 study is a phase II RCT, with a limited number of enrolled subjects. Further observation of the safety and clinical real-world application status of the sidibemab combination regimen is needed in a larger sample size prospective observational cohort study. The primary endpoint of this study is the safety events of the sidibemab combination regimen.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Colorectal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years old, gender not restricted; 2. Advanced colorectal cancer confirmed by histopathology; and confirmed as MSS/pMMR type by immunohistochemistry or genetic testing; 3. The investigators evaluate that the treatment regimen of cediranib combined with immune checkpoint inhibitors is applicable; 4. Clear consciousness, able to answer questions correctly; 5. Capable of using mobile phones and accessing the internet, with 3G/4G/5G function of smart mobile devices. Exclusion Criteria: 1. There are serious complications that interfere with the efficacy and safety analysis; 2. The investigators determined that the subjects were not suitable for inclusion in this study.

Locations (1)

Outcomes

Primary Outcomes

Grade 3-4 adverse effects rate

Rate of HDACi and immunotherapy and others treatments related severe adverse events

Time frame: From date of randomization until the date of death from any cause, assessed up to 2 years]

Secondary Outcomes

Objective response rate（ORR）

Objective response is defined as a complete response (CR ) or partial response (PR) according to RECIST v.1.1 or iRECIST

Time frame: about a year

Overall survival (OS)

Time from randomization to date of death due to any cause . according to the RECIST version 1.1 or iRecist recorded in the time period between randomization death to any cause.

Time frame: 2 years

Progression-free survival（PFS）

Time from randomization to date of Disease progression or death due to any cause.according to the RECIST version 1.1 or iRecist recorded in the time period between randomization and disease progression or death to any cause.

Time frame: 2 years

Duration of Response（DOR）

Time from randomization to date of the first assessment of the tumor as CR (Complete Response) or PR (Partial Response) until the first assessment of PD (Progressive Disease) or death for any reason.according to the RECIST version 1.1 or iRecist.

Time frame: 2 years

Clinical benefit rate （CBR）

Time from randomization to date of the first assessment of the tumor as CR (Complete Response) or PR (Partial Response) or SD (Stable Disease)rate.according to the RECIST version 1.1 or iRecist.

Time frame: 2 years

Patient-reported Outcomes (PRO) and Treatment Outcomes of Chinese Patients With MSS-type Advanced Colorectal Cancer Who Received the Zidovudine Combination Regimen in the Real World

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts