Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer

NCT04743102 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Chao Yang Hospital

Phase

Not applicable

Started

2021-01-01

Last updated

2023-02-21

Condition(s) studied

Rectal CancerNeoadjuvant TherapyComplete RemissionMetastasis

Investigational drug(s) / intervention(s)

multi-points and full-thickness Biopsytraditional cCR

multi-points and full-thickness Biopsy: Four points around the tumor site and center of the tumor site full-thickness Biopsy

traditional cCR: diginal examination, endoscopy test, rectal MRI, and serum CEA level

Study summary

Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Adult male and female, between 18 and 80 years old; * Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma; * The distance from the lower margin of the tumor to the anal margin ≤12 cm (endoscope) or to the anorectal ring ≤8 cm; * The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia; * Initial local MRI stage was T2 or T3A or T3B, N0-2, negative for extramural vascular invasion (EMVI), circumferential ential resection margin (CRM), and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis; * CCR patients evaluated after neoadjuvant therapy (no mass or ulcer found on digital rectal examination;Endoscopic examination showed no other changes except flat scar, telangiectasia or pallor of mucosa.MRI or rectal ultrasound showed no residual tumor in the primary site and lymphatic drainage area.Serum carcinoembryonic antigen (CEA) was normal. * Signing informed consent for surgery. Exclusion Criteria: * Previous history of malignant colorectal tumor; * Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery; * Unresectable lymph node metastasis; * Recently diagnosed with other malignant tumors; * Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment; * ASA rating ≥IV and/or ECOG physical status score ≥2 points; * Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases cannot tolerate surgery; * a history of serious mental illness; \- pregnant or lactating women; * Those with uncontrolled infection; * Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study

Primary outcome measure(s)

Clinical Complete Response rate — 8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer
Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer
pathological complete remission — 2 weeks after patients received radical operation
No tumor cell found in surgical specimens

Trial sites (1)

Facility	City	Region	Status
Beijing Chaoyang Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04743102 on ClinicalTrials.gov ↗ ← All trials in China