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New treatment option for Rectal Cancer
Official title Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma
ClinicalTrials.gov ID: NCT05752136
What this study is testing
What is Envafolimab?
Envafolimab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who are willing to receive neoadjuvant therapy.
- ≧18 years old.
- 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.
- Histologically diagnosed as rectal adenocarcinoma.
- The clinical staging by pelvic contrast-enhanced CT and pelvic high-resolution MRI were cT2-4a N+, cT3/T4a N0.
You likely can't join if
- History of other malignant diseases in the past 5 years.
- Patients with metastases from other sites (stage IV patients).
- Patients with clinical staging of T1-2N0 or T4b, or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
- Known allergic to oxaliplatin, capecitabine, PD-L1 monoclonal antibody and other drugs.
- Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
See the full eligibility criteria
- Patients who are willing to receive neoadjuvant therapy.
- ≧18 years old.
- 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.
- Histologically diagnosed as rectal adenocarcinoma.
- The clinical staging by pelvic contrast-enhanced CT and pelvic high-resolution MRI were cT2-4a N+, cT3/T4a N0.
- MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment .
- The patient has good compliance and can come to the hospital for re-examination as required.
- ECOG Scale of Performance Status score 0-1 point.
- Have not received anti-tumor and immunotherapy before enrollment.
- 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.
- Voluntarily participate in this study and sign the informed consent.
- History of other malignant diseases in the past 5 years.
- Patients with metastases from other sites (stage IV patients).
- Patients with clinical staging of T1-2N0 or T4b, or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
- Known allergic to oxaliplatin, capecitabine, PD-L1 monoclonal antibody and other drugs.
- Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
- dMMR or MSI-H patients.
- 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...
- 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...
- Active autoimmune disease that may worsen while receiving immunostimulants.
- Known history of positive HIV test or known acquired immunodeficiency syndrome.
- 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).
- Received any other experimental drug treatment or participated in another treatment clinical trial within 30 days before screening
- 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.
- Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, etc.
- Other conditions that the investigator judges that the patient is not suitable to participate in the clinical study, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.