Clinical trial · Interventional
Rectal Artery Infusion Chemotherapy Combined With Anti-PD1 Antibody for MSS LARC
Rectal Artery Infusion Chemotherapy of Oxaliplatin Plus Capecitabine Combined With Anti-PD1 Antibody After Induction Chemotherapy for Microsatellite Stable Locally Advanced Rectal Cancer：a Prospective Single-arm Phase II Study
NCT05307198CI-TRIAL-00070362RAICunknownPhase 2ClinicalTrials.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 study is to explore whether rectal artery infusion chemotherapy combined with anti-PD1 antibody is an effective neoadjuvant therapy for the microsatellite stable 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 |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | Anti-PD1 Monoclonal Antibody | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Rectectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rectal Artery Infusion Chemotherapy
- description
- Patients receive 2 cycles of Capecitabine and Oxaliplatin (CapeOx) chemotherapy and evaluated with rectum Magnetic Resonance Imaging (MRI). Patients with more than 20% regression of maximum diameter of rectal tumor in MRI image will entry into next step of rectal artery infusion of Oxaliplatin and oral Capecitabine（1000mg/㎡）with anti-PD1 antibody（200mg）every 3 weeks for 2 cycles.Then those patients will receive rectectomy including anterior resection or abdominoperineal resection by open or laparoscopy with TME.
- interventionNames
- Drug: Oxaliplatin
- Procedure: Rectectomy
- Drug: Capecitabine
- Drug: Anti-PD-1 monoclonal antibody
Primary outcomes (1)
- measure
- pCR rate
- timeFrame
- 1 day of postoperative pathological examination.
- description
- the pathological complete remission rate of the rectal carcinoma
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically diagnosed rectal adenocarcinoma * Age ≥18 years old and ≤75 years old * MRI stage T3-4aNany and TanyN1-2, but not T4b and no distant metastasis * Life expectancy of 1 year The above * Informed consent, no contraindications to chemotherapy exist * The distance from the lower edge of the tumor to the anus is between 5cm to 12cm by MRI Exclusion Criteria: * Refused to participate in this study * Multifocal colorectal cancer * Past history of malignant tumors, except for basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ * Unable to receive chemotherapy , such as but not limited to bone marrow suppression, etc * Major organ diseases (such as but not limited to COPD, coronary heart disease and renal insufficiency, etc.) acute attack and or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia and myocarditis, etc.), ASA score\> 3 * Mental disorder or illiteracy or language and communication barriers cannot understand the research plan * There are contraindications to arterial puncture, such as but not limited to severe arteriosclerosis or even atresia, coagulation dysfunction, long-term use of anticoagulant drugs and cannot be stopped, etc * Rectal tumor has obstruction or high risk of obstruction and or there is bleeding and/or perforation * Peripheral sensory nerve disorder, unable to receive oxaliplatin chemotherapy * Lateral pelvic lymph node metastasis (mainly supplied by internal iliac artery) * Pregnancy or breastfeeding * Unable to accept MRI examination * Consecutive use of glucocorticoids for more than 3 days within 1 month before signing the consent form * Tumor directly invades or adheres to adjacent organs、structures(T4b) or tumor invaded MRF（Mesoretal Fascia） * Other scenarios deemed inappropriate by the investigators
References
Publications (0)
Data not yet available
No reference posted for this study.