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NCT06014944Not yet recruitingPhase 2

Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody

A Single-arm, Single-center, Prospective Clinical Study of Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody for Neoadjuvant Therapy of PMMR/MSS Type Middle and Low Locally Advanced Rectal Cancer

Source: ClinicalTrials.gov · Last updated 31 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The investigators conduct a single-arm, single-center, prospective clinical study enrolling patients diagnoses with pMMR / MSS type middle and low locally advanced rectal cancer who had not received systemic anti-tumor therapy to explore the efficacy and safety of short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody as neoadjuvant therapy.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
28 Jul 2023
Start date
Sept 2023
Primary completion date
Dec 2028
Lead sponsor
Changhai Hospital
NCT number
NCT06014944

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From Sept 2023 to the primary completion date, Dec 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 1.Unable to comply with the research program or research procedures ; 2.Patients with surgical taboos ; 3.Patients with metastatic disease or recurrent rectal cancer ; 4.Patients with familial adenomatous polyposis ( FAP ), hereditary nonpolyposis colorectal cancer ( HNPCC ), active Crohn 's disease or active ulcerative colitis ; 5.Patients with other malignant tumors within 5 years before enrollment, except for basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ ; 6.Severe cardiovascular diseases, including unstable angina or myocardial infarction, occurred within 6 months before enrollment ; 7.Subjects who were allergic to the study drug or any of its adjuvants ; 8.Participated in other domestic unapproved or unlisted drug clinical trials within 4 weeks before enrollment and received corresponding experimental drug treatment ; 9.International normalized ratio ( INR ) \> 1.5 or activated partial thromboplastin time ( APTT ) \> 1.5 × ULN ; 10.Investigators judged clinically significant electrolyte abnormalities ; 11.There was uncontrolled hypertension before enrollment, which was defined as : systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg ; 12.There were poorly controlled diabetes before enrollment ( after regular treatment, fasting glucose concentration ≥ CTCAE grade 2 ) ; 1.3.13.Before enrollment, there are any diseases or states that affect drug absorption, or patients cannot take oral drugs ; 14.Before entering the group, there were gastrointestinal diseases such as gastric and duodenal active ulcers and ulcerative colitis, or other conditions that may cause gastrointestinal bleeding and perforation determined by the researchers ; 15.Severe active bleeding, hemoptysis ( fresh blood \> 5 mL within 4 weeks ) or thromboembolic events occurred within 12 months before enrollment ( package ).

Who the study is looking for

  • This study has been fully understood and voluntarily signed informed consent ;
  • Age 18-75 years old ( including 18 and 75 years old ) ; rectal adenocarcinoma was histologically confirmed as pMMR / MSS type ( according to the detection criteria of the institutional testing center, it can be detected by immunohistochemistry, PCR or NGS ), and was staged as stage II ( T3-4N0 ) or stage III ( T1-4N1-2 ) by MRI and CT.
    • 4.MRI was used to evaluate the middle and low rectal cancer below 10 cm from the anal margin of the tumor ; 5.Patients who were recommended for neoadjuvant therapy after evaluation by the Multidisciplinary Oncology Committee ; 6.ECOG physical condition 0-1 points ; 7.Expected survival ≥ 2 years ; 8.No previous anti-tumor treatment has been received ; the function of vital organs meets the following requirements ( not allowed to use any blood components and cell growth factors within \* 14 days before enrollment ) : Absolute neutrophil count ≥ 1.5 × 109 / L ; platelet ≥ 100 × 109 / L ; hemoglobin ≥ 90g / L ; total bilirubin \< 1.5 times ULN ; aLT and / or AST \< 2.5 times ULN ; serum creatinine \< 1.5 times ULN ; endogenous creatinine clearance rate ≥ 50ml / min ; 10. Women of childbearing age need to take effective contraceptive measures ; 11.good compliance, with follow-up.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.