Clinical trial: Vactosertib in Combination With Pembrolizumab in Metastatic Colorectal or Gastric Cancer (NCT03724851)

Eligibility criteria:
Inclusion Criteria:

          1. WHO / ECOG /PS of 0 or 1 at enrollment

          2. Must have a life expectancy of at least 12 weeks

          3. Patients with histologically or cytologically confirmed advanced or metastatic
             colorectal cancer who have disease progression after treatment with all available
             therapies including fluoropyrimidine and oxaliplatin or irinotecan for metastatic
             disease that are known to confer clinical benefit, or are intolerant to treatment, or
             refuse standard treatment.

          4. Histologically- or cytologically- confirmed, advanced or metastatic diffuse-type
             adenocarcinoma of the stomach or gastroesophageal (GE) junction who have had disease
             progression after at least two previous courses of chemotherapy for metastatic
             disease, which should include fluoropyrimidine and platinum.

          5. Confirmation of measurable disease based on RECIST 1.1

          6. ICI-naïve patients

          7. Adequate organ and marrow function as defined below: Bilirubin≤1.5 ×ULN ,AST (SGOT)
             and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for patients with liver metastases) ,INR OR PT
             ≤1.5 × ULN , ANC ≥1500/µL , Platelets ≥100 000/µL, Hemoglobin ≥9.0 g/dL or ≥5.6
             mmol/L1, Creatinine ≤1.5 × ULN

        Exclusion Criteria:

          1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with
             an agent directed to another stimulatory or co-inhibitory T-cell receptor

          2. Has received prior radiotherapy within 2 weeks of start of study treatment.

          3. Has received a live vaccine within 30 days prior to the first dose of study drug

          4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

          5. Has a known additional malignancy that is progressing or has required active treatment
             within the past 3 years.

          6. Has known CNS metastases and/or leptomeningeal involvement

          7. Judgement by the investigator that the patient should not participate in the study .
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment