Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07183865

Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R)

Led by Fudan University · Updated on 2025-09-19

44

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label, single arm, phase 2 study. The study is to evaluate the activity of combination therapy of hypofractionated radiotherapy, Irinotecan Hydrochloride Liposome plus 5-FU and leucovorin (NALIRIF), Anti-PD1 and target therapy in patients with locally recurrent rectal cancer (LRRC). The inclusion LRRC patients were failed to oxaliplatin treatment in prior chemotherapy or chemoradiotherapy due to toxicity or progression. Patients will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation for pelvic recurrence, 25-50Gy/5Fx irradiation for all metastasis sites, and 8 cycles of NALIRIF + anti-PD1 + target therapy, followed by multidisciplinary team (MDT) for decision: radical surgery, sustained system +/- local treatment of non resection. The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, complete response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment.

CONDITIONS

Official Title

Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18-75 years old at the time of signing the informed consent form.
  • ECOG performance status 0-1.
  • Pelvic recurrence confirmed by MRI or enhanced CT.
  • At least one measurable pelvic lesion according to RECIST 1.1.
  • No more than 5 distant metastasis lesions and no more than 3 metastatic organs.
  • No prior radiotherapy within 6 months.
  • Failed oxaliplatin treatment in prior chemotherapy or chemoradiotherapy due to toxicity or progression.
  • Investigator determined life expectancy of at least 24 weeks.
  • Adequate organ function (bone marrow, liver, kidney, and clotting) within 7 days before first treatment without blood products or hematopoietic stimulating factors.
  • Non-pregnant and non-lactating patients.
  • Effective contraceptive methods used during the study and up to 6 months after last treatment.
  • Fully informed and willing to provide written informed consent.
Not Eligible

You will not qualify if you...

  • Previous immunotherapy or Irinotecan Hydrochloride Liposome treatment.
  • Neutrophil count less than 1.5 x 10^9/L.
  • Platelet count less than 100 x 10^9/L (less than 80 x 10^9/L if liver metastasis).
  • Hemoglobin less than 90 g/L.
  • Blood transfusion within 2 weeks before enrollment.
  • Total bilirubin above 1.5 times upper limit of normal (2.5 times if liver metastasis).
  • AST or ALT above 2.5 times upper limit of normal (5 times if liver metastasis).
  • Creatinine above 1.5 times upper limit of normal or creatinine clearance below 50 ml/min.
  • APTT or PT above 1.5 times upper limit of normal.
  • Serious electrolyte abnormalities.
  • Urinary protein 2+ or higher, or 24-hour urine protein 1.0 g or higher.
  • Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg).
  • Active gastrointestinal diseases such as ulcers, ulcerative colitis, bleeding tumors, or unhealed perforations or fistulas.
  • History of arterial or deep vein thrombosis within 6 months or bleeding tendency within 2 months.
  • History of heart disease within 6 months including heart failure, recent heart attack, unstable angina, bypass surgery, or significant cardiac dysfunction.
  • Uncontrolled malignant pleural effusion, ascites, or pericardial effusion.
  • Clinically detectable second primary cancer or other malignancies within 5 years except certain treated skin, cervical, or bladder cancers.
  • History of liver disease including active hepatitis B or C infection or liver cirrhosis.
  • Pregnant or lactating women or those unwilling to use strict contraception.
  • Investigator judged unsuitability due to clinical or lab abnormalities or compliance issues.
  • Serious mental disorders.
  • Brain metastases larger than 3 cm or total volume greater than 30 cc.
  • Evidence of spinal cord compression or tumors within 3 mm of spinal cord on MRI.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

Z

Zhen Zhang, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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