Short-course radiation with immunotherapy for advanced rectal cancer

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma: a Prospective, Multicenter, Randomized Controlled Study (PRECAM-R)

This study is testing a new treatment that combines short radiation, a specific immune therapy, and chemotherapy to see if it helps people with advanced rectal cancer before surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (Academic / other)
• Drugs / interventions: immunotherapy, prednisone, chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05752136 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a new treatment approach for locally advanced rectal adenocarcinoma by combining short-course radiotherapy with the PD-L1 monoclonal antibody Envafolimab and CAPEOX chemotherapy. The study aims to assess the efficacy and safety of this combination as a neoadjuvant therapy before surgery. Additionally, it will explore the characteristics of patients who may benefit from this treatment through multi-omics sequencing analysis, aiming to develop an efficacy prediction model. The trial is designed to address the limitations of current preoperative treatment methods for this type of cancer.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed rectal adenocarcinoma and specific clinical staging.

Not a fit: Patients who have previously received anti-tumor or immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with locally advanced rectal cancer.

How similar studies have performed: While this approach is innovative, similar studies combining radiotherapy with immunotherapy have shown promising results, suggesting potential for success.

Eligibility criteria

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:

    * White blood cell count\>3.5×109/L, absolute value of neutrophils\>1.8×109/L, platelet count ≥75×109/L, hemoglobin ≥100g/L;

      * INR≤1.5, and APTT≤1.5 times the upper limit of normal or partial prothrombin time (PT) ≤1.5 times the upper limit of normal;

        * Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST \< 5 times the upper limit of normal;

          * 24h creatinine clearance \>50mL/min or serum creatinine \<1.5 times the upper limit of normal.
11. Voluntarily participate in this study and sign the informed consent.

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.
11. Known history of positive HIV test or known acquired immunodeficiency syndrome.
12. Patients who are using immunosuppressive agents, except for the following conditions:

    * Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections);

      * Physiological doses of systemic corticosteroids ≤10 mg/day prednisone or equivalent;

        * Steroids used to prevent allergic reactions (eg, before CT scan).
13. Received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening
14. Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures.
15. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, etc.
16. Other conditions that the investigator judges that the patient is not suitable to participate in the clinical study, etc.

Where this trial is running

Hangzhou, Zhejiang

• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: sheng dai — Sir Run Run Shaw Hospital
• Study coordinator: Sheng Dai, MD&PhD

Conditions Rectal Cancer