Tislelizumab plus IL‑2 and CapeOX before surgery for locally advanced rectal cancer

Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study (PICM)

This trial will test whether adding the PD‑1 drug tislelizumab and interleukin‑2 to standard CapeOX chemotherapy and radiotherapy before surgery helps people with locally advanced MSS rectal cancer achieve more tumor shrinkage and complete pathological responses.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: tislelizumab, chemotherapy, immunotherapy
• Locations: 4 sites (Nanjing, Jiangsu and 3 other locations)
• Trial ID: NCT06884670 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized Phase 2 trial comparing neoadjuvant tislelizumab combined with interleukin‑2 and CapeOX plus radiotherapy versus standard neoadjuvant therapy in patients with locally advanced, MSS/pMMR rectal adenocarcinoma. Eligible adults (18–75 years, ECOG 0–1) receive the combination treatment prior to planned curative surgery, with tumor response assessed by imaging and pathology of the surgical specimen. The co‑primary endpoints are objective response rate (ORR) and pathological complete response (pCR), and safety is monitored throughout treatment. Patients with metastatic disease, prior PD‑1 therapy, or active autoimmune conditions are excluded and the trial is conducted at several hospitals in Jiangsu province, China.

Who should consider this trial

Good fit: Ideal candidates are adults (18–75) with histologically confirmed, locally advanced (T3–T4 or node‑positive) MSS/pMMR rectal adenocarcinoma, good performance status (ECOG 0–1), adequate organ function, and no prior systemic therapy for colorectal cancer.

Not a fit: Patients with metastatic (stage IV) disease, prior systemic or PD‑1/PD‑L1/CTLA‑4 immunotherapy, active autoimmune disease, HIV/AIDS, or those requiring chronic immunosuppression are unlikely to benefit or are excluded from the trial.

Why it matters

Potential benefit: If successful, this combination could increase preoperative tumor downstaging and pCR rates, potentially improving surgical outcomes and long‑term prognosis.

How similar studies have performed: Checkpoint inhibitors have shown clear benefit mainly in MSI‑high colorectal cancers, while neoadjuvant immunotherapy combinations for MSS rectal cancer remain experimental with encouraging early signals but are not yet proven.

Eligibility criteria

Inclusion Criteria:

1. Males and females aged between 18 and 75 years;
2. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
3. Histologically confirmed rectal adenocarcinoma;
4. Clinical stage T3-T4 or any T with node-positive (N+) disease: locally advanced;
5. Microsatellite stable (MSS) status;
6. Adequate hematological, hepatic, and renal functions.

Exclusion Criteria:

1. Patients with metastatic disease (Stage IV); recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent non-colorectal cancer malignancies.
2. Patients who have previously received systemic anticancer therapy for colorectal cancer; or have been treated with PD-1, PD-L1, or CTLA-4 antibodies.
3. Patients with any active autoimmune disease; known or tested positive for Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or a history requiring steroid or immunosuppressive drug treatment.
4. Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
5. Patients who experienced any Grade 2 or higher toxicities due to prior treatments (as classified by the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5), which have not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected history of hypersensitivity to any of the drugs used in the trial.
6. Pregnant or breastfeeding women.

Where this trial is running

Nanjing, Jiangsu and 3 other locations

• Nanjing BenQ Hospital — Nanjing, Jiangsu, China (Recruiting)
• Jiangsu province hospital — Nanjing, Jiangsu, China (Recruiting)
• Xuzhou Central hospital — Xuzhou, Jiangsu, China (Recruiting)
• The Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Yueming Sun

Conditions Rectal Cancer; Tislelizumab; Interleukin-2; MSS/pMMR rectal cancer