Clinical trial · Interventional
TIME in Immunotherapy Combined With nCRT for Rectal Cancer
The Therapeutic and Prognostic Implications of Tumor Immune Microenvironment in The Neoadjuvant Immunotherapy Combined With Chemoradiotherapy for Rectal Cancer
- 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)
This is an open-label, prospective phase II clinical trial to evaluate the therapeutic and prognostic implications of tumor immune microenvironment in the neoadjuvant immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of 100 patients will be enrolled in this trial. The primary endpoint is the complete response rate, defined as the proportion of patients who achieve pathological complete response (pCR) or clinical complete response (cCR) without evidence of distant metastasis on post-treatment or preoperative assessment. The long-term prognosis and adverse effects will also be evaluated and analyzed.
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 |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Long-course radiation therapy | Radiation | — | UNRESOLVED |
| PD-1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemoradiotherapy plus PD-1 inhibitor
- description
- Capecitabine 1650mg/m2 is given 5 days a week in parallel with radiotherapy 45 to 50 Gy during 5 consecutive weeks. Tislelizumab is given on day 1 of week 2, 5 and 8 at 200 mg i.v. 8-12 weeks after completion of radiation therapy, patients undergo total mesorectal excision (TME). If the investigator and the subject opt for a "watch-and-wait" strategy after completing neoadjuvant therapy, a one-year follow-up will be conducted. If no additional surgery is performed due to disease-related reasons by the end of the follow-up period, this outcome is recognized as a clinical complete response (cCR).
- interventionNames
- Drug: PD-1 inhibitor
- Drug: Capecitabine
- Radiation: Long-course radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant chemoradiotherapy
- description
- Capecitabine 1650mg/m2 is given 5 days a week in parallel with radiotherapy 45 to 50 Gy during 5 consecutive weeks. 8-12 weeks after completion of radiation therapy, patients undergo total mesorectal excision (TME).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years and ≤75 years on the day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 3. Histologically proven rectal adenocarcinoma. 4. \<12 cm from anal verge. 5. Clinical stage of T3/T4 or N positive and M0 6. No previous chemotherapy, radiotherapy, immunotherapy or surgical treatment 7. No immune system disease (e. g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic vasculitis, scleroderma, mixed connective tissue disease, dermatomyositis (DM), hyperthyroidism, hypothyroidism, ulcerative colitis (UC), autoimmune hemolytic anemia (AIHA) or human immunodeficiency virus (HIV) infection. 8. Adequate hepatic and renal function to chemoradiotherapy, immunotherapy and surgery. 9. Willing and able to provide written informed consent. Exclusion Criteria: 1. Allergic to any component of chemotherapy or immunotherapy; 2. Patients with multiple primary colorectal cancer; 3. Other malignant tumors within 5 years, except for adequately treated cervical carcinoma in situ or cutaneous basal cell carcinoma, or basically controlled localized prostate cancer or surgically excised ductal carcinoma in situ of breast; 4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgical resection; 5. Prior or planed organ/bone marrow transplant 6. Patients who receive systemic steroid therapy or immunosuppressive agents within 30 days before enrollment in the study; 7. Pregnant or lactating women 8. Patients with a history of severe mental illness or being unable to comply with the research protocols. 9. Patients who have contraindications to chemoradiotherapy, immunotherapy or surgery. 10. Patients who have any other conditions that investigator judges unsuitable to participate.
References
Publications (0)
Data not yet available