Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05628038

The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer

Led by Fudan University · Updated on 2024-10-01

93

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study is a prospective, single-center, single-arm, two-cohort, phase II clinical trial. Patients aged 18 years or older who had pelvic recurrence rectal cancer with or without resectable distant metastasis, with treatment naive disease (cohort A) or progressive disease after first-line chemotherapy (cohort B), Eastern Cooperative Oncology Group performance status of 0-1, will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history), 18 weeks toripalimab and investigator's choice of chemotherapy +/- target therapy, and stereotactic ablative radiotherapy (SABR) for all metastatic lesions between chemoimmunotherapy cycles, followed by multidisciplinary team (MDT) for decision:follow-up of complete response (CR), radical surgery, sustained treatment of non resection, or exit. The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment. Shanghai Junshi Biomedical Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has purchased liability insurance for clinical trial subjects.

CONDITIONS

Official Title

The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer

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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Pelvic recurrence confirmed by MRI or enhanced CT with at least one measurable pelvic lesion.
  • No more than 5 distant metastatic lesions and metastatic involvement of no more than 3 organs.
  • No prior radiotherapy within the last 6 months.
  • Cohort A: pelvic recurrence patients with no prior first-line chemotherapy.
  • Cohort B: patients with disease progression or new lesions after first-line chemotherapy.
  • Investigator-estimated life expectancy of at least 24 weeks.
  • Adequate organ function (bone marrow, liver, kidney, and clotting) within 7 days before first treatment without recent blood products or stimulating factors.
  • Not pregnant or lactating, and use of effective contraception during the study and for 6 months after last treatment.
  • Fully informed and willing to provide written consent for participation.
Not Eligible

You will not qualify if you...

  • Neutrophil count less than 1.5 x 10^9/L, platelet count less than 100 x 10^9/L (or less than 80 x 10^9/L for liver metastasis), or hemoglobin less than 90 g/L; no blood transfusion within 2 weeks before enrollment.
  • Total bilirubin above 1.5 times the upper limit of normal (ULN), or above 2.5 times ULN in patients with liver metastasis.
  • AST or ALT greater than 2.5 times ULN, or greater than 5 times ULN in patients with liver metastasis.
  • Creatinine above 1.5 times ULN or creatinine clearance below 50 ml/min.
  • Prolonged APTT or PT greater than 1.5 times ULN.
  • Serious electrolyte imbalances.
  • Urinary protein of 2+ or higher, or 24-hour urine protein greater than or equal to 1.0 g.
  • Uncontrolled high blood pressure (systolic >140 mmHg or diastolic >90 mmHg).
  • Active gastrointestinal diseases causing bleeding or risk of perforation.
  • Recent arterial or deep vein thrombosis within 6 months or bleeding tendency within 2 months.
  • Heart disease within 6 months including heart failure, heart attack, severe angina, bypass surgery, or low heart function.
  • Uncontrolled malignant pleural effusion, ascites, or pericardial effusion.
  • Previous treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, PD-L2, CTLA-4, or related pathways.
  • Second primary cancer or other malignancies within 5 years except certain skin, cervical, or bladder cancers.
  • Liver disease including hepatitis B or C infection or liver cirrhosis.
  • Pregnant or lactating women or unwillingness to use strict contraception.
  • Investigator judgment of unsuitability due to clinical or lab abnormalities or compliance issues.
  • Serious mental disorders.
  • Brain metastases larger than 3 cm or total volume over 30 cc.
  • Evidence of spinal cord compression or tumors close to 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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