Chemoradiotherapy followed by Immunotherapy for Rectal Cancer
Neoadjuvant Long-course Chemoradiotherapy Followed by PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
This study is testing a new treatment for locally advanced rectal cancer that combines radiation with an immunotherapy drug to see if it helps patients respond better and keep their sphincter function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | radiation, Sintilimab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06493240 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a treatment regimen combining capecitabine-based long-course radiotherapy with the PD-1 inhibitor Sintilimab in patients with locally advanced rectal cancer. Participants will receive 50.4Gy of radiation followed by three cycles of Sintilimab, administered every two weeks. The primary goal is to determine the pathologic complete response (pCR) rate, while secondary goals include assessing the rate of sphincter preservation and monitoring adverse events.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with biopsy-confirmed locally advanced rectal adenocarcinoma and no distant metastasis.
Not a fit: Patients with a history of previous anti-tumor treatments or significant immune system disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and potentially increase the chances of organ preservation for patients with locally advanced rectal cancer.
How similar studies have performed: While the combination of chemoradiotherapy and immunotherapy is being explored, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 18\~75 * ECOG score 0\~2 * biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge * no distant metastasis, staged II/III (T4b excluded) by MRI * maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MR * willing and able to comply with study protocol * consent to the use of blood and tissue specimens for study * no history of previous anti-tumor treatment (e.g. radiation, chemo, immuno, bio, herbal, etc.) * no disorders/diseases of immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, hyperthyroidism/hypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.) * no significant dysfunction of major viscera (e.g. heart, lung, liver, kidney, etc.) * no jaundice or gastrointestinal obstruction * no acute/ongoing infection * no significant irregularities in blood routine test and biochemical test results, particular requirements include: neutrophils≥1.5×109/L, HGB≥80g/L, platelet≥100×109/L, serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, ALT、AST≤2.5×ULN * no social or mental disorder * for women of child-bearing age, a negative result of serological pregnancy test is required, and effective contraception measures from inclusion till 60 days after the last dose of study drug is required Exclusion Criteria: * multiple cancers, or with concomitant malignant tumors besides rectal cancer * having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years * history of recent major surgery * with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.) * with uncontrolled, severe, concomitant diseases of any sort * allergic to any of the ingredients under study * estimated survival ≤ 5 years due to any reason * preparing for or having previously received organ or bone marrow transplant * having received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to inclusion * for patients with history of disorder of central nervous system, investigator discretion is required as to whether the clinical severity prevents the signing of informed consent or affects the patient or oral medication compliance * with other conditions/issues that may affect the study results or cause the study treatment to be terminated halfway (e.g. alcoholism, drug abuse, etc.) * pregnant or lactating women, or women intending on conception during treatment period
Where this trial is running
Beijing, Beijing
- Peking University People's Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Zhanlong Zhanlong, M.D. — Peking University People's Hospital
- Study coordinator: Zhanlong Shen, M.D.
- Email: shenzhanlong@pkuph.edu.cn
- Phone: +86 13810230190
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.