NCT05507112Active, not recruitingPhase 2

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 · Last updated 7 Jul 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 100 (estimated)
First submitted: 17 Jul 2022
Start date: 20 Dec 2022
Primary completion date: 30 May 2025
Lead sponsor: Peking Union Medical College Hospital
Diseases: Colorectal cancer
NCT number: NCT05507112

What you commit to

Study type: Interventional · Phase 2
Planned participants: 100
From 20 Dec 2022 to the primary completion date, 30 May 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Prior or planed organ/bone marrow transplant
Patients who receive systemic steroid therapy or immunosuppressive agents within 30 days before enrollment in the study;
Patients who have contraindications to chemoradiotherapy, immunotherapy or surgery.

Other illness

Allergic to any component of chemotherapy or immunotherapy;
Patients with multiple primary colorectal cancer;
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;
Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgical resection;
Patients with a history of severe mental illness or being unable to comply with the research protocols.
Patients who have any other conditions that investigator judges unsuitable to participate.

Other

Pregnant or lactating women

Who the study is looking for

Age ≥ 18 years and ≤75 years on the day of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Histologically proven rectal adenocarcinoma.
\<12 cm from anal verge.
Clinical stage of T3/T4 or N positive and M0
No previous chemotherapy, radiotherapy, immunotherapy or surgical treatment
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.
Adequate hepatic and renal function to chemoradiotherapy, immunotherapy and surgery.
Willing and able to provide written informed consent.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Peking Union Medical College Hospital Coordinator of this site? Confirm its status	Beijing	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.