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

Capital Medical University

Status: Enrolling

Conditions: Metastasis; Complete Remission; Neoadjuvant Therapy; Rectal Cancer

Treatments: Diagnostic Test: traditional cCR; Procedure: multi-points and full-thickness Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04743102

BIOPSY-01

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Biopsy cCR

Experimental group

Description:

Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, we add multi-points and full-thickness Biopsy to further improve the accuracy of cCR after neoadjuvant therapy for rectal cancer.

Treatment:

Procedure: multi-points and full-thickness Biopsy

Conventional cCR

Active Comparator group

Description:

Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, to study accuracy of cCR after neoadjuvant therapy for rectal cancer.

Treatment:

Diagnostic Test: traditional cCR