NCT05969847

Brief Summary

Patients diagnosed with locally advanced very low rectal cancer were chosen to participate in a comprehensive neoadjuvant therapy (TNT) protocol. This treatment regimen consisted of preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy and enverolimab. For patients who achieved clinical complete response (cCR) or near-clinical complete response (ncCR) after undergoing TNT, an organ-preserving strategy involving local full-thickness resection was implemented.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
20mo left

Started Aug 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Aug 2023Dec 2027

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

4.4 years

First QC Date

July 23, 2023

Last Update Submit

July 23, 2023

Conditions

Rectal Cancer

Keywords

Locally advanced very low rectal cancerTotal neoadjuvant therapyHypofraction radiotherapyCAPOXEnvafolimabLocal excision

Outcome Measures

Primary Outcomes (1)

  • Organ preservation

    The rectum is intact, owing to no radical total mesorectal excision (TME), curative (R0) salvage surgery by local excision (LE), and no permanent stoma (including a never reversed protective stoma or a stoma owing to toxicities and/or poor functional outcomes).

    36 months

Secondary Outcomes (8)

  • ypT0-1 rate

    36 months

  • Pathological complete response (pCR) rate

    36 months

  • Acute and late toxicity

    36 months

  • Local recurrence rate

    36months

  • Local regional recurrence rate

    36 months

  • +3 more secondary outcomes

Study Arms (1)

split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision

EXPERIMENTAL

Patients diagnosed with locally advanced very low rectal cancer were chosen to undergo a total neoadjuvant therapy (TNT) regimen. This regimen consisted of preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy and enverolimab. For patients who achieved clinical complete response (cCR) or near-clinical complete response (ncCR) after TNT, an organ-preserving strategy involving local full-thickness resection was implemented. Patients who achieve non-clinical complete response are subjected to traditional TME surgery.

Radiation: split-course hypofraction radiotherapyDrug: CAPOXDrug: EnvafolimabProcedure: Local excision

Interventions

split-course hypofraction radiotherapyRADIATION

After reaching a cumulative radiotherapy dose of 25Gy in the entire pelvic cavity (PTV1), the treatment field was subsequently narrowed to solely focus on the primary tumor (PTV2), with a total dose of 35Gy administered. All patients will undergo fractionated radiotherapy, following a regimen of 7Gy per fraction, delivered every 3 weeks for five cycles.

Also known as: hypofraction radiotherapy
split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision
CAPOXDRUG

Drug: Oxaliplatin,130mg/m2，ivgtt，d1,for 6 cycles. Drug: Capecitabine,1000mg/m2，po，bid，d1-14, for 6 cycles.

Also known as: Capecitabine+Oxaliplatin
split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision
EnvafolimabDRUG

Envafolimab is administered by subcutaneous injection. The recommended dose is 300 mg per 3 weeks (Q3W) for 6 cycles.

Also known as: KN035
split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision
Local excisionPROCEDURE

Local full-thickness resection is employed for patients with clinical complete response (cCR) or near-clinical complete response (ncCR) following TNT.

split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75.
  • Histopathology confirmed the rectal adenocarcinoma,cT3-4N0 or cT1-4N1-2. The tumor's lower margin ≤ 2cm from the anorectal ring's upper edge (based on MRI measurement).
  • Eastern tumor cooperation group (ECOG) status:0-2.
  • American Association of Anesthesiologists (ASA) status: I-III.
  • No previous systemic therapy, including chemotherapy, immunotherapy, or radiotherapy for rectal cancer.
  • No previous history of pelvic radiotherapy.
  • Sufficient organ function based on the following parameters:
  • An absolute neutrophil count≥ 1.5 × 109 / L, a thrombocyte count ≥ 100 × 109/ L, a glomerular filtration rate (calculated using the Cockcroft-Gault formula) with a creatinine level ≤ 1.5 × ULN or a creatinine clearance \> 50ml/min, and AST and ALT levels ≤ 2.5 × ULN or a total bilirubin level ≤ 1.5 × ULN.
  • Effective contraception during the study.
  • Patients are willing and able to comply with the protocol during the study period.
  • Patients with written informed consent

You may not qualify if:

  • Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and adenocarcinoma developed from inflammatory bowel disease.
  • Metastasis to para-aortic, lateral, or inguinal lymph nodes has been identified.
  • Suspected distant metastasis in organs other than para-aortic, lateral, or inguinal lymph nodes is being considered.
  • Known hypersensitivity to platinum drugs or capecitabine.
  • Patients receiving concomitant treatment with drugs that interact with capecitabine or oxaliplatin (such as flucytosine, phenytoin, and warfarin).
  • According to the New York Heart Association (NYHA) classification, III or IV heart failure, and angina pectoris have occurred in the past six months.
  • Uncontrolled active infection or severe concomitant systemic disease.
  • Patients who need immunosuppressive therapy for organ transplantation.
  • Uncontrolled epilepsy or mental illness.
  • Pregnant or lactating female patients.
  • Non-compliance or researchers believe that the patient will not be able to complete the entire trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pan Chi

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

XELOXenvafolimabMastectomy, Segmental

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Officials

  • Pan Chi, MD

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pan Chi, MD

CONTACT

+8613675089677cp3169@163.com

Jiabin Zheng

CONTACT

+8613365910080xhyykjk@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

August 15, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)