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Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM) | Clinical Trials | Clareo Health

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

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM): an Open Label, Prospective, Single Arm Clinical Trial

NCT05216653•Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

Summary

Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer. According to the existing theory, the use of PD-L1 monoclonal antibody after short-course radiotherapy may be the best solution. In this study, the investigators will perform single-cell sequencing of participants tissue samples, fully explore the multi-dimensional omics information of tumors and microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients who are willing to receive neoadjuvant therapy.
•2. ≧18 years old.
•3. Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 12 cm from the anus.
•4. Histologically diagnosed as rectal adenocarcinoma.
•5. The clinical staging by pelvic contrast-enhanced CT and pelvic high-resolution MRI were cT2-4a N+, cT3/T4a N0.
•6. MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment .
•7. The patient has good compliance and can come to the hospital for re-examination as required.
•8. ECOG Scale of Performance Status score 0-1 point.
•9. Have not received anti-tumor and immunotherapy before enrollment.
•10. Laboratory inspections must meet the following standards:
+5 more criteria

Exclusion Criteria

•1. History of other malignant diseases in the past 5 years.
•2. Patients with metastases from other sites (stage IV patients).
•3. Patients with clinical staging of T1-2N0 or T4b, or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.
•4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
•5. Known allergic to oxaliplatin, capecitabine, PD-L1 monoclonal antibody and other drugs.
•6. Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
•7. dMMR or MSI-H patients.
•8. The patient is accompanied by any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, hypertension uncontrolled by medication, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial Infarction, congestive heart failure, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease; disease affecting the patient's life.
•9. The disease (such as mental illness, etc.) or condition (such as alcoholism or drug abuse, etc.) associated with the patient will increase the risk of the patient receiving the trial drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results.
•10. Active autoimmune disease that may worsen while receiving immunostimulants.
+9 more criteria

Locations (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

April 7, 2022

Primary Completion Date

March 31, 2023

Completion Date

March 5, 2025

Last Updated

March 13, 2025

Enrollment

ACTUAL participants

Conditions

MSS Locally Advanced Rectal Adenocarcinoma

Interventions

Envafolimab

DRUG

Oxaliplatin

DRUG

Capecitabine

DRUG

Short-course Radiation

RADIATION

TME surgery, total mesorectal excision

PROCEDURE