CClinicalTrials.gg
Not yet recruitingNCT06035133Updated Sep 13, 2023

Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy

An interventional study of CapeOX + cetuximab and CapeOX + bevacizumab in Rectal Cancer, sponsored by Tang-Du Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Tang-Du Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
213
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

(1) To evaluate the oncological effects of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode on TRG, Anal sphincter preservation surgery rate / rectal preservation surgery rate, cCR rate, pCR rate and other oncological effects in patients with middle and low LARC; (2) Evaluate the R0 resection rate, LARS score, urination function and sexual function score, local recurrence rate, and 3-year DFS and OS of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode, resolve the current dispute about the Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT treatment mode of LARC, provide a new mode for LARC treatment, and hopefully rewrite the diagnosis and treatment guidelines for rectal cancer.

02

Conditions studied

  • Rectal Cancer

Browse trials for

03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 213 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged between 18 and 70;
  • Histologically confirmed adenocarcinoma of rectum;
  • The distance from the lower edge of the tumor to the anus is ≤ 10cm;
  • ECOG score ≤ 1;
  • Have not received any anti-tumor treatment before;
  • Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2; M0 chest and abdomen CT showed no obvious metastasis. (Note: PET-CT is recommended when small nodules can not be identified by liver or lung CT, and can still be included in the group when considering the possibility of metastasis)
  • Hematological indicators and liver and kidney function within 7 days are within the normal range;
  • Sign the informed consent form and be able to follow the research and /or follow-up procedures.

Exclusion criteria

Exclusion Criteria:

  • Have serious basic diseases, such as heart disease, renal failure, severe liver failure or liver failure, coagulation dysfunction, etc; Postoperative recurrence of colorectal cancer;
  • The patient had a history of malignant tumor within 5 years;
  • Pregnant or lactating women;
  • The patient has a history of adjuvant radiotherapy for other system diseases, and surgical contraindications, so it is not suitable for surgery;
  • The patient has had radiotherapy and chemotherapy records before this visit;
  • Distant metastasis was found during operation;
  • Patients with poor radiotherapy compliance and difficult cooperation;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
213 participants (estimated)

Study arms

  • Experimental
    radiotherapy removal TNT plus group

    Six induction chemotherapy rounds of the CapeOX regimen were administered. RAS, BRAF, and MSI were found when the first patients were examined. Patients were given CapeOX + cetuximab for RAS wild-type patients, CapeOX + bevacizumab for RAS mutant patients, and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks. A surgical procedure was carried out two weeks after consolidation chemotherapy ended.

    Drug: CapeOX + cetuximab · Drug: CapeOX + bevacizumab · Radiation: radiotherapy

Interventions

  • DrugCapeOX + cetuximab

    CapeOX + cetuximab for RAS wild-type patients and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.

  • DrugCapeOX + bevacizumab

    CapeOX + bevacizumab for RAS mutant patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.

  • Radiationradiotherapy

    radiotherapy

06

What researchers measure

Primary outcomes

  1. tumor regression grading, TRG

    Reference resist 1.1 rating

    Time frame: one month after surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06035133
Lead sponsor
Tang-Du Hospital
Responsible party
Sponsor
First posted
Sep 13, 2023
Start date
Nov 10, 2023 (estimated)
Primary completion
Nov 10, 2024 (estimated)
Completion
Nov 10, 2027 (estimated)
Last update
Sep 13, 2023

Study contacts

Nan Wang, Dr
Contact
wangnandoc@163.com
15719286297

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion