Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06525428

Standard Systemic Therapy Combined With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

Led by Fudan University · Updated on 2024-07-29

96

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

TORCH-M is a prospective, single-arm, two-cohort, investigator-initiated phase II trial to investigate the efficacy and safety of standard systemic therapy in combination with high/low-dose radiotherapy plus toripalimab in paitents with microsatellite stable metastatic colorectal cancer (MSS mCRC). Eligible patients will be assigned to two cohorts according to previous treatment: a first-line cohort A and a second-line cohort B. Patients in both arms will first receive one cycle of standard systemic therapy and toripalimab, followed by high/low-dose radiotherapy, and then continue with standard systemic therapy and toripalimab.The survival benefits, response rates, and adverse effects will be analyzed.

CONDITIONS

Official Title

Standard Systemic Therapy Combined With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histopathologically confirmed microsatellite stable (MSS) or proficient mismatch repair (pMMR) adenocarcinoma of the colon or rectum.
  • At least one metastatic lesion evaluable for radiotherapy and response evaluation per RECIST 1.1.
  • Treatment-naive patients for first-line cohort or patients progressed after first-line therapy or stopped first-line therapy due to unacceptable toxicity for second-line cohort.
  • Prior radiotherapy completed at least 4 weeks before enrollment.
  • Adequate bone marrow function: neutrophils ≥ 1.5 × 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 10^9/L.
  • Adequate liver function: ALT/AST ≤ 2.5 times upper limit of normal (ULN), creatinine ≤ 1 ULN.
  • Signed informed consent and good compliance.
Not Eligible

You will not qualify if you...

  • Neutrophils < 1.5 × 10^9/L, platelets < 100 × 10^9/L (or < 80 × 10^9/L if liver metastasis), or hemoglobin < 90 g/L; blood transfusion within 2 weeks before enrollment.
  • Total bilirubin > 1.5 ULN (or > 2.5 ULN if liver metastasis).
  • AST or ALT > 2.5 ULN (or > 5 ULN if liver metastasis).
  • Creatinine > 1.5 ULN or creatinine clearance < 50 ml/min.
  • Prolonged APTT or PT > 1.5 ULN.
  • Serious electrolyte imbalances, urinary protein ≥ 2+, or 24-hour urine protein ≥ 1.0 g/24h.
  • Uncontrolled hypertension (systolic > 140 mmHg or diastolic > 90 mmHg).
  • Active gastrointestinal diseases such as ulcers, bleeding tumors, unhealed perforations, or fistulas.
  • History of arterial or venous thrombosis within 6 months, bleeding tendencies within 2 months.
  • Recent heart disease within 6 months including heart failure, severe angina, myocardial infarction, or low heart function.
  • Uncontrolled malignant pleural effusion, ascites, or pericardial effusion.
  • Prior treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or other checkpoint inhibitors.
  • Clinically detectable second primary malignancies or recent other cancers within 5 years except certain treated skin, cervical, or bladder cancers.
  • History of liver diseases including hepatitis B or C infection or liver cirrhosis.
  • Pregnant or breastfeeding women, or unwillingness to use strict contraception during the study.
  • Significant mental disorders.
  • Brain metastases larger than 3 cm or total volume over 30 cc.
  • Evidence of spinal cord compression or tumors within 3 mm of the spinal cord on MRI.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200030

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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