A Small-sample, Real-world Study of Sintilimab Plus Bevacizumab/Cetuximab Plus XELOX Regimen for Conversion Therapy in Patients With Advanced Colorectal Cancer

NCT05544812 | Unknown

• 1 other identifier: yangjianjun-2
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to acssess the efficacy and the safety of Sintilimab plus bevacizumab/cetuximab plus XELOX regimen for conversion therapy in patients with advanced colorectal cancer

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• AE

  Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0

  2-year

Secondary Outcomes (3)

• ORR

  1-year

• DCR

  1-year

• OS

  2-year

Study Arms (1)

experimental

Patients in this group had previously received the following treatment regimens: Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W

Drug: Sintilimab ，bevcizumab/cetuximab，XELOX

Interventions

Sintilimab ，bevcizumab/cetuximab，XELOX DRUG

Patients in this group had previously received the following treatment regimens: Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W

experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with initially unresectable advanced colorectal cancer

You may qualify if:

• Patients had to meet all the following conditions to be enrolled in this study:
• Pathological diagnosis of colorectal adenocarcinoma; Ambulatory cases, aged 18-75 years; ECOG score less than or equal to 1; Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy);
• Baseline blood routine and biochemical parameters of the subjects met the following criteria:
• Blood routine examination standards shall meet: A. WBC \& GT; 4.0 x 10 / L; b. ANC \> 1.5 x 10 / L; C. the ANC acuity 1.5 x 109 / L; D. HB ≥ 80 g/L; E. PLT acuity 100 x 109 / L;
• Biochemical tests shall meet the following standards:
• A. TBIL 1.5 x ULN or less; B. ALT and AST \& LT; 2.5×ULN, ALT and AST \& LT for patients with liver metastases; 5 x ULN; C. BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min(Cockcroft-Gault formula).
• No history of other tumors； Be willing and able to follow the protocol during the study； Withdraw from the study at any time during the study without any loss; No history of other tumors; Be willing and able to follow the protocol during the study; Written informed consent was provided prior to study screening and was understood by the patient； Expected life ≥ 6 months

You may not qualify if:

• Patients were not admitted to the study if they met any of the following criteria:
• Cured basal cell carcinoma of the skin and uterus in patients with other malignancies in the past； Cervical carcinoma in situ is excluded;
• Patients with known positive HER-2 test;
• Pregnant or lactating women are in the reproductive period and have not taken effective contraceptive measures, or have fertility requirements during the study period;
• Serious and uncontrolled medical diseases and infections; Chronic bowel disease or short bowel syndrome;
• Major organ failure, such as compensatory cardiopulmonary, liver and kidney failure; Severe abnormal liver and kidney function metabolism, affecting the normal drug metabolism;
• Patients with investigator-identified propensity for gastrointestinal bleeding and/or abnormal coagulation (INR \& GT; 1.5);
• Active HBV or HCV;
• Patients with peripheral neuropathy NCT-CTCAE ≥ grade 2;
• Patients who were allergic to the drug in the study protocol were not suitable to participate in the clinical study.
• Patients with rheumatic diseases, such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, such as ankylosing spondylitis, psoriasis arthritis, gout, pseudogout, etc. Laboratory tests included positive antinuclear antibody, anti-DS-DNA antibody, anti-SM antibody, anti-phospholipid antibody, HLA-B27, rheumatoid factor (RF-igm), anti-cyclic citrulline (CCP) antibody, rheumatoid factor IgG and IgA, antinuclear factor, anti-keratin antibody, etc.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Yang Jianjun

Xi’an, Shanxi, 712000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jianjun Yang

CONTACT

+8613572533693; jianjunyang66@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 16, 2022
• Study Start: May 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: June 30, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)