Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05752136

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma

Led by Sir Run Run Shaw Hospital · Updated on 2023-05-08

108

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer.In view of the shortcomings of the current preoperative neoadjuvant treatment model for locally advanced rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 2 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy.

CONDITIONS

Official Title

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients willing to receive neoadjuvant therapy
  • At least 18 years old
  • Tumor located 12 cm or less from the anus confirmed by digital rectal exam, colonoscopy, and high-resolution pelvic MRI
  • Histologically diagnosed with rectal adenocarcinoma
  • Clinical staging cT2-4a N+ or cT3/T4a N0 by pelvic contrast-enhanced CT and high-resolution MRI
  • pMMR or MSS status confirmed by MMR protein or MSI gene detection before treatment
  • Good compliance and able to attend required hospital re-examinations
  • ECOG Performance Status score 0-1
  • No prior anti-tumor or immunotherapy treatments before enrollment
  • Laboratory values meeting specified blood counts, coagulation, liver, and kidney function thresholds
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • History of other malignant diseases within the past 5 years
  • Presence of metastases from other sites (stage IV patients)
  • Clinical staging T1-2N0, T4b, or positive lateral lymph nodes by imaging
  • Intestinal obstruction, perforation, bleeding requiring emergency surgery
  • Known allergies to oxaliplatin, capecitabine, PD-L1 monoclonal antibody, or related drugs
  • Pathological types of signet ring cell carcinoma or mucinous adenocarcinoma
  • dMMR or MSI-H status
  • Unstable systemic diseases such as severe infection, uncontrolled diabetes, uncontrolled hypertension, unstable angina, recent stroke or heart attack, severe heart failure or arrhythmia, serious liver, kidney, or metabolic diseases
  • Conditions affecting patient life expectancy or compliance, including mental illness, alcoholism, or drug abuse
  • Active autoimmune diseases that may worsen with immunostimulants
  • Known positive HIV or AIDS diagnosis
  • Use of immunosuppressive agents except specified low-dose or topical steroids
  • Participation in other experimental drug trials within 30 days before screening
  • Pregnant or breastfeeding women, or those planning pregnancy; men or women unwilling to use effective contraception
  • Vulnerable populations such as mentally ill, cognitively impaired, critically ill patients, or minors
  • Other conditions deemed unsuitable by the investigator for study participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310016

Actively Recruiting

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Research Team

S

Sheng Dai, MD&PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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