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

Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer

NCT04743102•Beijing Chao Yang Hospital

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

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;
+1 more criteria

Locations (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

January 1, 2021

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2028

Last Updated

February 21, 2023

Enrollment

260

ESTIMATED participants

Conditions

Rectal CancerNeoadjuvant TherapyComplete RemissionMetastasis

Interventions

multi-points and full-thickness Biopsy

PROCEDURE

traditional cCR

DIAGNOSTIC_TEST

Contacts

Jiagang Han

CONTACT

86-10-85231604 hanjiagang@ccmu.edu.cn

Zhiwei Zhai

CONTACT

86-10-85231604 913916215@qq.com

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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: February 21, 2023Data 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.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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