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NCT Number: NCT07116577

Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC

This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jinan Central Hospital

Jinan, Shandong, 250000, China

Location contact

Meili Sun, Director, Department of Oncology, MD, PhD

PRINCIPAL_INVESTIGATOR

Yawen Zhen, Associate Director, Department of Oncology

CONTACT

[email protected]

+86 150 2001 0760

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 75 years .
  • Histologically confirmed unresectable colorectal adenocarcinoma.
  • Patients must have received at least one prior line of oxaliplatin-, irinotecan-, or 5-FU-based therapy with documented progression or intolerance.
  • Documented KRAS and BRAF mutation status (mutant or wild-type) must be available.
  • Palliative radiotherapy targeting primary or metastatic lesions is planned.
  • At least one measurable lesion per RECIST v1.1 exists.
  • ECOG score of 0-1 and life expectancy ≥12 weeks.
  • Adequate bone marrow, hepatic, and renal function must be demonstrated.
  • Fertile patients commit to using effective contraception during and for 6 months post-treatment.

Exclusion criteria

  • History of Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy deemed contraindications for retreatment.
  • Radiation or systemic anticancer therapy within 14 days prior to first study treatment.
  • Active CNS metastases and/or leptomeningeal disease (LMD). Symptomatic interstitial lung disease (ILD), active pneumonitis, uncontrolled infections, or non-healing wounds/fistulae.
  • Intestinal perforation risks: active diverticulitis, intra-abdominal abscess, GI obstruction, or cancer-related peritoneal carcinomatosis.
  • Uncontrolled or symptomatic serous cavity effusions (pleural, ascites, pericardial).
  • Uncontrolled cardiovascular/cerebrovascular diseases.
  • Medical/social conditions that may compromise study results or lead to premature termination per investigator judgment.

Treatment and study plan

Palliative radiotherapy

Radiation

Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.

Iparomlimab and Tuvonralimab

Drug

5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).

TAS-102

Drug

35 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks).

Bevacizumab

Drug

7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Primary outcomes

  1. ORR

    Time frame: approximately 4 months after the last subject participating in

    The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

Secondary outcomes

  1. PFS

    Time frame: approximately 12 months after the last subject participating in

    the proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects.

  2. OS

    Time frame: approximately 12 months after the last subject participating in

    The time from the starting date of study drug to the date of death due to any cause.

  3. DCR

    Time frame: approximately 4 months after the last subject participating in

    The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects

  4. Safety (adverse event)

    Time frame: Up to approximately 2 years.

    The rates of adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Yawen Zhen, Associate Director, Department of Oncology

CONTACT

[email protected]

+86 150 2001 0760

Sponsors and collaborators

Lead sponsor

Jinan Central Hospital

Other

Registry information

Official study title

A Single-Arm, Exploratory Study of Palliative Radiotherapy Combined With Iparomlimab and Tuvonralimab, Trifluridine/Tipiracil (TAS-102), and Bevacizumab in Later-Line Treatment of Advanced Colorectal Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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