QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Colorectal Carcinoma

Treatments: Drug: Bevacizumab; Drug: Oxaliplatin injection; Drug: Capecitabine; Drug: QL1706

Study type: Interventional

Funder types: Industry

Identifiers

NCT05799820

QL1706-208

Details and patient eligibility

About

This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Subjects participate voluntarily and sign informed consent.
• 2. Age ≥ 18 and ≤ 80 years old, male or female.
• 3. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
• 4. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).

Exclusion criteria

• 1. Diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
• 2. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
• 3. Has active autoimmune disease that has required systemic treatment in past 2 years.
• 4. Significant cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

QL1706

Experimental group

Treatment:

Drug: QL1706

QL1706 in combination with bevacizumab and XELOX

Experimental group

Treatment:

Drug: Capecitabine

Drug: QL1706

Drug: Bevacizumab

Drug: Oxaliplatin injection