Combining Envafolimab with Chemoradiotherapy for Advanced Rectal Cancer
Single-arm, Single-center, Exploratory Phase II Clinical Study of Envafolimab Combined With Chemoradiotherapy in the Treatment of Locally Advanced pMMR/MSS Rectal Cancer
This study is testing if adding a new drug called Envafolimab to standard treatment can help people with advanced rectal cancer do better and stay healthier.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Yunnan Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation, envafolimab, immunotherapy |
| Locations | 1 site (Kunming, Yunnan) |
| Trial ID | NCT06239870 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Envafolimab in combination with chemoradiotherapy for patients with locally advanced rectal cancer that is pMMR/MSS. The study aims to improve treatment efficacy by addressing the limitations of standard therapies, which often fail to control micrometastases effectively. Participants will receive Envafolimab throughout the neoadjuvant therapy process, with careful monitoring of their disease characteristics and overall health. The trial is designed to evaluate the safety and effectiveness of this combined approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed locally advanced rectal adenocarcinoma and specific health criteria.
Not a fit: Patients with distant metastasis or other serious health conditions that could affect survival may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved survival rates and reduced recurrence in patients with locally advanced rectal cancer.
How similar studies have performed: While there have been studies exploring combinations of therapies for rectal cancer, the specific use of Envafolimab in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 1) Disease characteristics
* Histologically confirmed rectal adenocarcinoma; Immunohistochemical confirmation as pMMR or/and pCR or/and NGS test as MSS;
* Tumor location within 12cm from anal margin;
* Locally advanced rectal cancer (stage II-III, i.e. cT3-4 and/or N+) as assessed by the UICC/AJCC TNM staging system (8th edition, 2017);
\* Preoperative staging method: pelvic MRI/ transrectal ultrasound combined with preoperative staging.
* No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal colostomy surgery;
* Preoperative chest, abdominal and pelvic CT to exclude distant metastasis. 2) Patient characteristics
* Age: 18 \~75 years old;
* Activity status score: ECOG 0-1;
* Life expectancy: more than 2 years;
* Hematology: WBC\>3500×106/L; PLT\>100000×106/L; Hb\>10g/dL;
* Liver function: SGOT and SGPT are less than 1.5 times of normal value; Bilirubin less than 1.5mg/dL;
* Kidney function: creatinine \<1.8mg/dL;
* Other: non-pregnant or breastfeeding women; No other malignant disease (other than non-melanoma or carcinoma in situ of the cervix) within 5 years or during the same period; Does not have a mental illness that prevents informed consent; There were no other serious diseases associated with shorter survival.
* Patients or family members can understand the study protocol and are willing to participate in the study, and sign a written informed consent;
* Good patient compliance, voluntary follow-up, treatment, laboratory tests, and other research steps as scheduled.
3) Prior treatment
* No previous rectal cancer surgery;
* No previous chemotherapy or radiation therapy;
* No previous biotherapy;
* Previous endocrine therapy: No restriction.
Exclusion Criteria:
* CRC for microsatellite highly unstable (MSI-H) or mismatch repair protein expression deficiency (dMMR); Chronic hepatitis B or C with a history or active HIV infection (high copy of viral DNA);
* Autoimmune diseases;
* Other active clinical serious infections (\>NCI-CTC version 3.0);
* Stage I patients;
* Preoperative evidence of distant metastasis;
* Dysfluid, organ function decompensation;
* A history of pelvic or abdominal radiotherapy;
* Multiple primary cancers;
* Patients whose seizures require management (such as steroid or antiepileptic therapy);
* A history of other malignancies within 5 years, except for cured cervical carcinoma in situ or skin basal cell carcinoma;
* Chronic inflammatory bowel disease, intestinal obstruction; Substance abuse and medical, psychological or social conditions that may interfere with the patient's participation in the study or the evaluation of the findings;
* A known or suspected allergy to the study drug or to any drug administered in connection with this trial;
* Any unstable conditions or conditions that may compromise patient safety and compliance
Where this trial is running
Kunming, Yunnan
- Envafolimab — Kunming, Yunnan, China (Recruiting)
Study contacts
- Study coordinator: Yunfeng Li, master
- Email: 13330445776@qq.com
- Phone: 13330445776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.