Clinical trial · Observational
Multi-omics Model Predicts Efficacy of Preoperative Neoadjuvant Chemoradiotherapy Combined PD-1 Antibody Therapy for Locally Advanced Rectal Cancer
NCT05368051CI-TRIAL-00058385unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical research is to establish a multi-omics model based on genomics,transcriptomics,gut microbiota in predicting pathologic response after neoadjuvant chemoradiotherapy combined PD-1 antibody given to patients with locally advanced rectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| long course radiotherapy + capecitabine + PD-1 monoclonal antibody | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- long course radiotherapy + capecitabine + PD-1 monoclonal antibody
- description
- long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer
- interventionNames
- Combination Product: long course radiotherapy + capecitabine + PD-1 monoclonal antibody
Primary outcomes (1)
- measure
- pathologic complete response(pCR)
- timeFrame
- 1 year
- description
- All the enrolled patients will receive total mesorectal excision (TME) 7-9 weeks after the end of long course radiotherapy. The rectal specimens will be evaluated by the pathologists who are experienced on the rectal cancer diagnosis according to the 1997 Dworak grading system. The rectal cancer will be classified into 5 grades. Grade 0-3 will be considered as non-pCR while grade 4 represent pCR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients have been fully aware of the content of this study and signed the informed consent voluntarily; * Patients with rectal cancers must satisfied all the following conditions: Stage II/III LARC (cT1-3N1-2M0);Tumor distal location ≤ 7 cm from anal verge (MRI diagnosed); * Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1; * Physical and viscera function of patients can withstand major abdominal surgery; * Patients are willing and able to follow the study protocol during the study; * Patients give consent to the use of blood and pathological specimens for study; * Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose. Exclusion Criteria: * Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time; * Patients underwent major surgery within 4 weeks prior to study treatment; * Patients have any condition affects the absorption of capecitabine through gastrointestinal tract; * Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; * Patients who are allergic to any of the ingredients under study; * Patients with severe concomitant diseases with estimated survival ≤ 5 years; * Patients with present or previous moderate or severe liver and kidney damage presently or previously; * Patients have received other study medications or any immunotherapy currently or in the past; * Patients preparing for or previously received organ or bone marrow transplant; * Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy; * Patients with congenital or acquired immune deficiency (such as HIV infection); * If patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance; * Patients with other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment and severe laboratory examination abnormalities. * Pregnant or lactating women
References
Publications (2)
- DERIVEDMa J, Sun S, Cheng X, Meng C, Zhao H, Fu W, Gao Y, Ma L, Yang Z, Yao H, Su J. Unraveling the role of gut microbiome in predicting adverse events in neoadjuvant therapy for rectal cancer. Hum Vaccin Immunother. 2024 Dec 31;20(1):2430087. doi: 10.1080/21645515.2024.2430087. Epub 2024 Dec 2. PMID 39623529
- DERIVEDYang Z, Ma J, Han J, Li A, Liu G, Sun Y, Zheng J, Zhang J, Chen G, Xu R, Sun L, Meng C, Gao J, Bai Z, Deng W, Zhang C, Su J, Yao H, Zhang Z. Gut microbiome model predicts response to neoadjuvant immunotherapy plus chemoradiotherapy in rectal cancer. Med. 2024 Oct 11;5(10):1293-1306.e4. doi: 10.1016/j.medj.2024.07.002. Epub 2024 Jul 23. PMID 39047732